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Dietary Reference Intakes for Sodium and Potassium (2019)

Chapter: Appendix E: Supplemental Literature Searches

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Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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Appendix E

Supplemental Literature Searches

The Agency for Healthcare Research and Quality systematic review, Sodium and Potassium Intake: Effects on Chronic Disease Outcomes and Risks (AHRQ Systematic Review) (Newberry et al., 2018), served as a foundational source of evidence for the committee. However, additional literature searches were needed in order to inform the committee’s decision regarding the different Dietary Reference Intake (DRI) categories. This appendix provides a description of the additional literature searches conducted for indicators not included in the AHRQ Systematic Review but considered potentially relevant. This appendix also includes the committee’s search for studies that would have qualified for the AHRQ Systematic Review, but were published after the last literature search conducted by the AHRQ Systematic Review investigators.

SUPPLEMENTAL LITERATURE SEARCH FOR POTASSIUM AND SODIUM BALANCE STUDIES

In order to minimize the duplication of resources, the committee’s supplemental literature search for balance studies drew from the references presented in three sources: Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate (2005 DRI Report) (IOM, 2005), the 2016 European Food Safety Authority (EFSA) Diet Reference Values (DRVs) for Potassium (EFSA, 2016), and the 2018 draft of the EFSA DRVs for Sodium (EFSA, 2018). These three sources were selected as each provided thorough summaries of evidence on balance studies and descriptions of losses in the urine, feces, and sweat. As the EFSA resources were

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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recently prepared, the committee expected both to reflect evidence on balance studies that had emerged since the 2005 DRI Report. Nevertheless, the committee also considered evidence provided through its other information-gathering activities, including comments submitted by the public and its public workshops. The committee notes that the EFSA DRVs for sodium report was in draft form at the writing of this report. The draft contained a comprehensive summary of evidence on sodium, but did not establish the reference values. The committee reviewed the summary of public comments on the intermediate draft of the DRVs for sodium, and did not find evidence that crucial studies had been omitted from the balance study summary (EFSA, 2017). The committee therefore determined that the DRVs for sodium draft report was a suitable resource from which to draw references on balance studies.

The committee compiled the references from each of the three sources cited in sections of those reports that summarized evidence on balance studies and losses in urine, feces, and sweat; one additional reference was submitted to the committee through the public comment mechanism. Across sodium and potassium, 77 references were identified. References were then reviewed using the following inclusion criteria: primary research study; crossover or sequential design; conducted for a minimum of 3 days; and conducted in normotensive, apparently healthy participants similar to the U.S. and Canadian populations. Studies using randomized parallel design trials were not included because high intra-individual variability might confound results. Summary tables of the literature are presented in Chapters 4 and 8.

SUPPLEMENTAL LITERATURE SEARCHES FOR EVIDENCE ON THE RELATIONSHIP BETWEEN SODIUM INTAKE AND HEADACHES

In its search for evidence to inform the sodium Tolerable Upper Intake Level, the committee identified headache as a potentially informative indicator. Evidence of the potential relationship was presented to the committee during its March 2018 public workshop (Whelton, 2018); in particular, three references were cited (Amer et al., 2014; Appel et al., 2001; Chen et al., 2016). To supplement the evidence presented to the committee, a supplementary literature search was conducted. The search strategy was aligned with the literature scans described in Appendix D (see Table D-2), which was modeled after the search strategy conducted in the AHRQ Systematic Review (Newberry et al., 2018). Specifically, three searches were conducted in PubMed to identify potentially relevant evidence of effect (i.e., randomized controlled trials), evidence of association (i.e., prospective cohorts and case-cohorts), and systematic reviews to reference

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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mine.1 The searches resulted in 58 references for the effect-related search, and 59 references for the association-related search; after deduplication, 87 unique references remained. The search also identified 14 systematic reviews, of which 1 was relevant to the relationship between sodium intake and headaches; reference mining the review article, however, did not reveal any additional studies. Titles and abstracts were screened by two independent reviewers for potential relevance to sodium intake and headaches; discrepancies were resolved through discussion. The title/abstract screening removed 85 publications. The remaining studies were presented to the committee at its March 2018 workshop. As such, the supplementary literature search on headaches revealed no additional studies. The committee’s assessment of the evidence on the relationship between sodium intake and headaches is presented in Chapter 9.

SUPPLEMENTAL LITERATURE SEARCHES ON ADDITIONAL INDICATORS IDENTIFIED THROUGH THE LITERATURE SCAN

The committee drew from diverse evidence sources to compile a comprehensive list of indicators that had been assessed in the literature as potentially having a relationship with potassium and sodium intakes (see Appendix D). Through literature scans, scoping searches, and expert scientific judgment, the committee narrowed the list and selected the following indicators for supplemental literature searches: blood lipids; bone health (fractures and bone mineral density); catecholamines; type 2 diabetes, glucose intolerance, and insulin sensitivity; and plasma renin activity.

Identifying High-Quality Systematic Reviews

To minimize the duplication of resources, the committee’s supplemental literature searches began with a search for recent, high-quality systematic reviews on all indicators of interest. The search was conducted in MEDLINE and the Cochrane Database of Systematic Reviews and was limited to systematic reviews published since January 1, 2013. The committee determined that systematic reviews older than 5 years would not be considered recent. Systematic reviews were included if they reported a literature search strategy, described study eligibility criteria, included a risk-of-bias assessment, and had a potassium or sodium exposure. The search returned

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1 The indicator-specific terminology for headache was ((“headache”[MeSH Terms] OR “headache”[All Fields]) OR (“head”[All Fields] AND “pain”[All Fields]) OR “head pain”[All Fields]) OR (“cephalodynia”[All Fields]) OR (“cephalalgia”[All Fields]) OR (“hemicranias”[All Fields]) OR (“migraine disorders”[MeSH Terms] OR (“migraine”[All Fields] AND “disorders”[All Fields]) OR “migraine disorders”[All Fields] OR “migraine”[All Fields]).

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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127 initial results. After removing duplicates, 90 were excluded based on a dual title/abstract screening, and an additional 23 were excluded after a full-text screening, leaving 6 relevant systematic reviews. Each of these systematic reviews was evaluated using the AMSTAR 2 tool (Shea et al., 2017) (see Table E-1).2 The AMSTAR 2 evaluation was conducted by two independent reviewers, and any conflicts were resolved through discussion. After considering the AMSTAR 2 assessment, one systematic review assessing the relationship between potassium intake and the risk of type 2 diabetes was excluded owing to failure to assess the effect of the risk of bias in the synthesis of evidence (Peng et al., 2017). Additionally, one systematic review assessing the effect of supplemental alkaline potassium salts on bone metabolism was identified (Lambert et al., 2015); however, it was not selected as a source of evidence because it had a narrow scope and would have necessitated a broader search to be conducted. These two systematic reviews were, however, used for reference mining to identify potentially relevant primary research articles. The remaining four systematic reviews were included and used to inform the committee’s evidence review (Aburto et al., 2013a,b; Graudal et al., 2017; He et al., 2013). The included systematic reviews addressed three of the committee’s indicators of interest: blood lipids, catecholamines, and plasma renin activity. Because of variations in the inclusion and exclusion criteria for the reviews, as well as the results, the committee was unable to combine the reviews. Instead, the committee evaluated each review independently with regard to the questions of interest, and included population and duration of included studies in order to synthesize the available information and draw conclusions.

Searching for Primary Studies

Because no high-quality, recent systematic reviews were identified on the relationship between sodium and potassium intakes and bone health or type 2 diabetes, glucose tolerance, and insulin sensitivity, a literature search to identify primary studies was conducted in Ovid MEDLINE to identify relevant randomized controlled trials and prospective cohort studies published since January 1, 2003, up to April 2018. The committee searched back to 2003 in order to include anything published since the 2005 DRI Report. The searches were limited to humans and English language publications.

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2 AMSTAR stands for A Measurement Tool to Assess Systematic Reviews.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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TABLE E-1 Summary of AMSTAR 2 Evaluation of Identified Systematic Reviews

Reference AMSTAR 2 Use in Committee’s Review
Criteriaa Partially Met Not Met
Aburto et al., 2013a List and justification of excluded studies None Source of evidence
Aburto et al., 2013b List and justification of excluded studies None Source of evidence
Graudal et al., 2017 None None Source of evidence
He et al., 2013 None Sources of funding reported Source of evidence
Lambert et al., 2015 Included studies described Review methods established prior to review
Duplicate data extraction
Sources of funding reported
Publication bias assessed if quantitative synthesis was done
Reference mining
Peng et al., 2017 Included studies described Review methods established prior to review
List and justification of excluded studies
Sources of funding reported
Impact of risk of bias assessed in evidence synthesis
Reference mining

NOTE: AMSTAR = A Measurement Tool to Assess Systematic Reviews.

aUnless otherwise noted as partially met or not met, all criteria were deemed to be met according to the AMSTAR 2 criteria. The AMSTAR 2 criteria for quality assessment is available at https://amstar.ca/docs/AMSTAR-2.pdf (accessed August 15, 2018).

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

Search Terms

The search strategy was aligned with the approach taken in the AHRQ Systematic Review. The search was conducted in MEDLINE using comprehensive search terms for bone health3 and type 2 diabetes.4 Comprehensive search terms were also used to capture all forms of sodium and potassium (e.g., supplements, sodium or potassium compounds), aligned with terms used in the AHRQ Systematic Review.

Inclusion/Exclusion Criteria

The search was limited to articles published since January 1, 2003. Randomized controlled trials and prospective cohort studies were included if they had a sodium or potassium intervention or exposure, or measured sodium or potassium intake. Other study designs were excluded, as were interventions where the effect of sodium or potassium could not be disaggregated from other effects. The complete inclusion/exclusion criteria are outlined in Tables E-2 through E-5 for sodium and potassium intakes and bone health outcomes, and in Tables E-6 through E-9 for sodium and potassium intakes and type 2 diabetes, glucose tolerance, and insulin sensitivity outcomes. The inclusion/exclusion criteria for population, Intervention/Intake, comparators, setting, and study design were generally aligned with criteria used in the AHRQ Systematic Review. Owing to differences in outcomes being searched, some revisions were made. For example, studies assessing bone mineral density outcomes were limited to 1-year duration or longer in order to reliably assess results, whereas other outcomes had a minimum duration of 4 weeks.

Screening and Selection

The search for these outcomes returned 2,287 results. After removing duplicates, dual screening titles and abstracts, and screening full-text articles, 14 relevant references were identified. Of these references, eight were on relationships with bone health outcomes (fracture and bone mineral density) and six were on type 2 diabetes, glucose tolerance, and insulin sensitivity outcomes. The characteristics of the studies are summarized in Tables E-10 through E-16.

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3 Including bone density, mineralization, osteoporosis, bone mineral content, fracture, falls, rickets, and tooth loss.

4 Including prediabetes, insulin resistance, and glucose tolerance.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

TABLE E-2 Inclusion Criteria for Studies to Assess the Effect of Sodium Intake on Bone Health Outcomes

Component Criteria
Population Studies in humans, except those exclusively in patients with end-stage renal disease, heart failure, HIV, cancer, patients with fractures, or patients who have undergone transplantation, or bariatric or gastric bypass.
Intervention/Intake Studies evaluating interventions to reduce dietary sodium intake that specify the oral consumption from food or supplements of quantified amounts of sodium and sodium chloride (salt) or sodium-to-potassium ratio will be eligible, with the exception of trial arms in which participants demonstrate a weight change of +/− 3 percent or more. Interventions simultaneously addressing sodium and potassium intake that document sodium-to-potassium ratio are eligible; all other multicomponent interventions in which the effect of sodium reduction cannot be disaggregated from other intervention components will be excluded.
Comparators Studies comparing interventions to placebo or control diets will be eligible. Studies comparing an experimental diet to usual diet, studies comparing levels of sodium intake, or studies that alter sodium-to-potassium ratio in other ways will be included if they control for other nutrient levels.
Outcomes Studies reporting on bone health outcomes (including fractures, falls, or performance measures of strength, and bone mineral density) will be eligible for inclusion.
Timing Studies with a duration of more than 1 year will be eligible for inclusion.
Setting Studies in outpatient settings will be eligible.
Study Design Randomized controlled trial (crossover or parallel arm).

NOTE: HIV = human immunodeficiency virus.

SOURCE: Criteria adapted from Newberry et al., 2018.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

TABLE E-3 Inclusion Criteria for Studies to Assess the Association Between Sodium Intake and Bone Health Outcomes

Component Criteria
Population Studies in humans, except those exclusively in patients with end-stage renal disease, heart failure, HIV, cancer, patients with fractures, or patients who have undergone transplantation, or bariatric or gastric bypass.
Intervention/Intake Studies that measure the intake (oral consumption from food or supplements of quantified amounts of sodium and sodium chloride [salt] or sodium-to-potassium ratio) with validated measures or that use biomarker values to assess sodium level (at least one 24-hour urinary analysis with or without reported quality control measure, chemical analysis of diet with intervention/exposure adherence measure, composition of salt substitute with intervention/exposure adherence measure, and food diaries with reported validation [adherence check, electronic prompts]) will be eligible. Observational studies that report a weight change of +/− 3 percent or more (in any exposure group) among adults; multicomponent studies that do not properly control for confounders; and studies relying only on serum sodium levels, composition of salt substitute without intervention/exposure adherence measure, food diaries without reported validation, use of a published food frequency questionnaire, or partial or spot urine without reported prediction equation will be excluded.
Comparators Studies comparing groups with different documented sodium intake or biomarker values for sodium will be eligible. Studies where differences in sodium intake or values are not reported independently of alteration of other nutrient levels will be excluded.
Outcomes Studies reporting on bone health outcomes (including fractures, falls, or performance measures of strength, and bone mineral density) will be eligible for inclusion.
Timing Studies with a duration of more than 1 year will be eligible for inclusion.
Setting Studies in outpatient settings will be eligible.
Study Design Prospective cohort studies (including case-cohort studies).

NOTE: HIV = human immunodeficiency virus.

SOURCE: Criteria adapted from Newberry et al., 2018.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

TABLE E-4 Inclusion Criteria for Studies to Assess the Effect of Potassium Intake on Bone Health Outcomes

Component Criteria
Population Studies in humans, except those exclusively in patients with end-stage renal disease, heart failure, HIV, cancer, patients with fractures, or patients who have undergone transplantation, or bariatric or gastric bypass.
Intervention/Intake Studies evaluating interventions to increase dietary potassium intake that specify the oral consumption from food or supplements of quantified amounts of potassium, potassium supplements, salt substitutes such as potassium chloride, or sodium-to-potassium ratio will be eligible, with the exception of trial arms in which participants demonstrate a weight change of +/− 3 percent or more among adults. Interventions simultaneously addressing sodium and potassium intake that document sodium-to-potassium ratio are eligible; all other multicomponent interventions in which the effect of sodium reduction cannot be disaggregated from other intervention components will be excluded.
Comparators Studies comparing interventions to placebo or control diets will be eligible. Studies comparing an experimental diet to usual diet, studies comparing levels of potassium intake, or studies that alter sodium-to-potassium ratio in other ways will be included if they control for other nutrient levels.
Outcomes Studies reporting on bone health outcomes (including fractures, falls, or performance measures of strength, and bone mineral density) will be eligible for inclusion.
Timing Studies with a duration of more than 1 year will be eligible for inclusion.
Setting Studies in outpatient settings will be eligible.
Study Design Randomized controlled trial (crossover or parallel arm).

NOTE: HIV = human immunodeficiency virus.

SOURCE: Criteria adapted from Newberry et al., 2018.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

TABLE E-5 Inclusion Criteria for Studies to Assess the Association Between Potassium Intake and Bone Health Outcomes

Component Criteria
Population Studies in humans, except those exclusively in patients with end-stage renal disease, heart failure, HIV, cancer, patients with fractures, or patients who have undergone transplantation, or bariatric or gastric bypass.
Intervention/Intake Studies that measure intake (oral consumption from food or supplements of quantified amounts of potassium, potassium supplements, salt substitutes such as potassium chloride, or sodium-to-potassium ratio) with validated measures or use biomarker values to assess potassium level (at least one 24-hour urinary analysis with or without reported quality control measure, chemical analysis of diet with intervention/exposure adherence measure, composition of potassium supplement with intervention/exposure adherence measure, use of a published food frequency questionnaire, and food diaries) will be eligible. Observational studies that report a weight change of +/− 3 percent or more (in any exposure group) among adults; multicomponent studies that do not properly control for confounders; and studies measuring potassium intake by reporting chemical analysis of diet without intervention/exposure adherence measures, composition of potassium supplement without intervention/exposure measure, or serum potassium will be excluded.
Comparators Studies comparing groups with different documented potassium intake, serum potassium levels, or urinary potassium excretion will be eligible. Studies where differences in potassium intake or values are not reported independently of alteration of other nutrient levels will be excluded.
Outcomes Studies reporting on bone health outcomes (including fractures, falls, or performance measures of strength, and bone mineral density) will be eligible for inclusion.
Timing Studies with a duration of more than 1 year will be eligible for inclusion.
Setting Studies in outpatient settings will be eligible.
Study Design Prospective cohort studies (including case-cohort studies).

NOTE: HIV = human immunodeficiency virus.

SOURCE: Criteria adapted from Newberry et al., 2018.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

TABLE E-6 Inclusion Criteria for Studies to Assess the Effect of Sodium Intake on Type 2 Diabetes, Glucose, and Insulin Outcomes

Component Criteria
Population Studies in humans, except those exclusively in patients with end-stage renal disease, heart failure, HIV, cancer, patients with fractures, or patients who have undergone transplantation, or bariatric or gastric bypass.
Intervention/Intake Studies evaluating interventions to reduce dietary sodium intake that specify the oral consumption from food or supplements of quantified amounts of sodium and sodium chloride (salt) or sodium-to-potassium ratio will be eligible, with the exception of trial arms in which participants demonstrate a weight change of +/− 3 percent or more. Interventions simultaneously addressing sodium and potassium intake that document sodium-to-potassium ratio are eligible; all other multicomponent interventions in which the effect of sodium reduction cannot be disaggregated from other intervention components will be excluded.
Comparators Studies comparing interventions to placebo or control diets will be eligible. Studies comparing an experimental diet to usual diet, studies comparing levels of sodium intake, or studies that alter sodium-to-potassium ratio in other ways will be included if they control for other nutrient levels.
Outcomes Studies reporting on type 2 diabetes mellitus, glucose intolerance, or insulin sensitivity will be eligible for inclusion. Studies reporting on type 1 diabetes and gestational diabetes will be excluded.
Timing Studies with a duration of more than 4 weeks will be eligible for inclusion.
Setting Studies in outpatient settings will be eligible.
Study Design Randomized controlled trial (crossover or parallel arm).

NOTE: HIV = human immunodeficiency virus.

SOURCE: Criteria adapted from Newberry et al., 2018.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

TABLE E-7 Inclusion Criteria for Studies to Assess the Association Between Sodium Intake and Type 2 Diabetes, Glucose, and Insulin Outcomes

Component Criteria
Population Studies in humans, except those exclusively in patients with end-stage renal disease, heart failure, HIV, cancer, patients with fractures, or patients who have undergone transplantation, or bariatric or gastric bypass.
Intervention/Intake Studies that measure the intake (oral consumption from food or supplements of quantified amounts of sodium and sodium chloride [salt] or sodium-to-potassium ratio) with validated measures or that use biomarker values to assess sodium level (at least one 24-hour urinary analysis with or without reported quality control measure, chemical analysis of diet with intervention/exposure adherence measure, composition of salt substitute with intervention/exposure adherence measure, and food diaries with reported validation [adherence check, electronic prompts]) will be eligible. Observational studies that report a weight change of +/− 3 percent or more (in any exposure group) among adults; multicomponent studies that do not properly control for confounders; and studies relying only on serum sodium levels, composition of salt substitute without intervention/exposure adherence measure, food diaries without reported validation, use of a published food frequency questionnaire, or partial or spot urine without reported prediction equation will be excluded.
Comparators Studies comparing groups with different documented sodium intake or biomarker values for sodium will be eligible. Studies where differences in sodium intake or values are not reported independently of alteration of other nutrient levels will be excluded.
Outcomes Studies reporting on type 2 diabetes mellitus, glucose intolerance, or insulin sensitivity will be eligible for inclusion. Studies reporting on type 1 diabetes and gestational diabetes will be excluded.
Timing Studies with a duration of more than 4 weeks will be eligible for inclusion.
Setting Studies in outpatient settings will be eligible.
Study Design Prospective cohort studies (including case-cohort studies).

NOTE: HIV = human immunodeficiency virus.

SOURCE: Criteria adapted from Newberry et al., 2018.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

TABLE E-8 Inclusion Criteria for Studies to Assess the Effect of Potassium Intake on Type 2 Diabetes, Glucose, and Insulin Outcomes

Component Criteria
Population Studies in humans, except those exclusively in patients with end-stage renal disease, heart failure, HIV, cancer, patients with fractures, or patients who have undergone transplantation, or bariatric or gastric bypass.
Intervention/Intake Studies evaluating interventions to increase dietary potassium intake that specify the oral consumption from food or supplements of quantified amounts of potassium, potassium supplements, salt substitutes such as potassium chloride, or sodium-to-potassium ratio will be eligible, with the exception of trial arms in which participants demonstrate a weight change of +/− 3 percent or more among adults. Interventions simultaneously addressing sodium and potassium intake that documents sodium-to-potassium ratio are eligible; all other multicomponent interventions in which the effect of sodium reduction cannot be disaggregated from other intervention components will be excluded.
Comparators Studies comparing interventions to placebo or control diets will be eligible. Studies comparing an experimental diet to usual diet, studies comparing levels of potassium intake, or studies that alter sodium-to-potassium ratio in other ways will be included if they control for other nutrient levels.
Outcomes Studies reporting on type 2 diabetes mellitus, glucose intolerance, or insulin sensitivity will be eligible for inclusion. Studies reporting on type 1 diabetes and gestational diabetes will be excluded.
Timing Studies with a duration of more than 4 weeks will be eligible for inclusion.
Setting Studies in outpatient settings will be eligible.
Study Design Randomized controlled trial (crossover or paralleled).

NOTE: HIV = human immunodeficiency virus.

SOURCE: Criteria adapted from Newberry et al., 2018.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

TABLE E-9 Inclusion Criteria for Studies to Assess the Association Between Potassium Intake and Type 2 Diabetes, Glucose, and Insulin Outcomes

Component Criteria
Population Studies in humans, except those exclusively in patients with end-stage renal disease, heart failure, HIV, cancer, patients with fractures, or patients who have undergone transplantation, or bariatric or gastric bypass.
Intervention/Intake Studies that measure intake (oral consumption from food or supplements of quantified amounts of potassium, potassium supplements, salt substitutes such as potassium chloride, or sodium-to-potassium ratio) with validated measures or use biomarker values to assess potassium level (at least one 24-hour urinary analysis with or without reported quality control measure, chemical analysis of diet with intervention/exposure adherence measure, composition of potassium supplement with intervention/exposure adherence measure, use of a published food frequency questionnaire, and food diaries) will be eligible. Observational studies that report a weight change of +/− 3 percent or more (in any exposure group) among adults; multicomponent studies that do not properly control for confounders; and studies measuring potassium intake by reporting chemical analysis of diet without intervention/exposure adherence measures, composition of potassium supplement without intervention/exposure measure, or serum potassium will be excluded.
Comparators Studies comparing groups with different documented potassium intake, serum potassium levels, or urinary potassium excretion will be eligible. Studies where differences in potassium intake or values are not reported independently of alteration of other nutrient levels will be excluded.
Outcomes Studies reporting on type 2 diabetes mellitus, glucose intolerance, or insulin sensitivity will be eligible for inclusion. Studies reporting on type 1 diabetes and gestational diabetes will be excluded.
Timing Studies with a duration of more than 4 weeks will be eligible for inclusion.
Setting Study Design Studies in outpatient settings will be eligible. Prospective cohort studies (including case-cohort studies).

NOTE: HIV = human immunodeficiency virus.

SOURCE: Criteria adapted from Newberry et al., 2018.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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TABLE E-10 Randomized Controlled Trial Assessing the Effect of Sodium Intake on Bone Health Outcomes

Reference (Location) Participants Intervention(s) Control Duration Results
Parallel Arm Randomized Controlled Trial
Ilich et al., 2010 (United States) 97 healthy, postmenopausal, Caucasian women Dietary advice to lower sodium intake to 1,500 mg/d; received ~630 mg/d calcium and ~400 IU/d vitamin D supplementation Received dietary advice to maintain sodium intake to 3,000 mg/d; received ~630 mg/d calcium and ~400 IU/d vitamin D supplementation 3 years No statistical difference observed in mean BMD of the forearm (p = .417), hip (p = .411), or spine (p = .695) between groups at baseline and 3 years.

NOTE: BMD = bone mineral density; IU/d = International Units per day; mg/d = milligrams per day.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

TABLE E-11 Randomized Controlled Trials Assessing the Effect of Potassium Intake on Bone Health Outcomes

Reference (Location) Participants Intervention(s) Control or Comparison Group Duration Results
Gregory et al., 2015 (United States) 83 postmenopausal women, with osteopeniaa Received 40 mmol/d K citrate plus daily supplementation with Citracal (630 mg/d calcium citrate and 400 IU/d vitamin D3) Received daily placebo capsules and supplementation with Citracal (630 mg/d calcium citrate and 400 IU/d vitamin D3) 12 months
  • Mean BMD remained stable over the 12-month study period in subjects treated with K citrate and control.
Jehle et al., 2013 (Switzerland) 169 adults, 65–80 years of age, without current treatment for low bone mineral densityb Received 60 mmol/d K citrate plus daily supplementation with calcium (500 mg/d) and vitamin D3 (400 IU/d) Received placebo tablets plus daily supplementation with calcium (500 mg/d) and vitamin D3 (400 IU/d) 24 months
  • aBMD increased at all skeletal sites in the K citrate group with no trend to plateau.
  • After 24 months, aBMD at L2–L4 increased by 1.7% ([95% CI: 1.0, 2.3], p < .001), net of placebo. Corresponding increases were 1.6% [95% CI: 1.1, 2.2] at femoral neck, 1.0% [95% CI: 0.5, 1.5] at total hip, and 1.3% [95% CI: 0.8, 1.7] in total body.
Macdonald et al., 2008 (United Kingdom) 203 postmenopausal women, 49–54 years of age Three treatment groups:
High-dose group received 55.5 mmol/d K citrate Low-dose group received 18.5 mmol/d K citrate
Received placebo tablets 24 months
  • Mean BMD loss at the spine in the placebo group was 1.8 ± 3.9% over 2 years.c
  • Apparently greater BMD loss (2.1 ± 3.2%)c in the treatment groups was not significant (p = .88).
  • For mean total hip, BMD loss was less in the placebo group (1.3 ± 2.3%)c than in the low-dose K citrate group (2.2 ± 2.3%),c but the difference was not significant (p = .14).
Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

TABLE E-11 Randomized Controlled Trials Assessing the Effect of Potassium Intake on Bone Health Outcomes

Reference (Location) Participants Intervention(s) Control or Comparison Group Duration Results
Diet group received additional 300 g/d fruit and vegetables

NOTE: aBMD = areal bone mineral density; BMD = bone mineral density; CI = confidence interval; g/d = grams per day; IU/d = International Units per day; K citrate = potassium citrate; mg/d = milligram per day; mmol/d = millimoles per day.

aDefined as a T-score at the lumbar spine or hip between −1.0 and −2.5.

bDefined as a T-score at lumbar spine, L2 through L4, of less than −2.5.

cValues presented as mean ± standard deviation.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
×

TABLE E-12 Prospective Cohort and Case-Cohort Studies Assessing the Association Between Potassium Intake and Bone Health Outcomes

Reference (Location) Participantsa Length of Follow-Up Intake Assessment Results
Hayhoe et al., 2015 (United Kingdom) 4,713 adults, 40–79 years of age 13.4 yearsb 7-day food diary
  • Positive trend in calcaneal BUA for women across increasing quintiles of potassium intake, not apparent in men; individual statistics did not remain significant with adjustment for multiple comparisons.
  • No statistically significant associations between potassium intake and risk of fracture.
Zhu et al., 2009 (Australia) 266 healthy women, 70–80 years of agec 5 yearsd One 24-hour urine assessment, conducted at baseline
  • Women in highest quartile of potassium excretion had a higher total hip BMD at year 1 (5%) and year 5 (6%), and significantly higher total body BMD (4%) and distal tibia total (7%) and trabecular vBMD (11%) at 5 years than those in the lowest quartile.e
Nieves et al., 2010 (United States) 125 healthy women, 18–26 years of agef 24 monthsg Modified 97-item FFQ administered at baseline and each follow-up visit
  • There was a positive relationship between increased intake of potassium and significant increases in hip and whole body BMD.h
Macdonald et al., 2004 (United Kingdom) 891 pre-, peri-, and postmenopausal healthy women, 50–59 years of age at follow-up 5–7 years FFQ, validated, conducted at baseline and follow-up
  • In premenopausal women only, significant positive association between BMD at femoral neck and energy-adjusted potassium intake.i
  • In analysis of all women, no evidence of association between nutrient intake and BMD.

NOTE: BMD = bone mineral density; BUA = broadband ultrasound attenuation; FFQ = food frequency questionnaire; vBMD = volumetric bone mineral density.

aTotal number of participants included in the analysis.

bMean length of follow-up.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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cMean age at baseline was 75.0 ± 2.7.

dThis is an intervention study; however, it is reported with cohort studies because the effect of potassium was not the basis of the intervention.

eAnalyses adjusted for baseline values of age, height, weight, calcium treatment group, energy intake, calcium intake, protein intake, and physical activity levels.

fMean age at baseline was 22.1 ± 2.6 years.

gThis is an intervention study; however, it is reported with cohort studies because the effect of potassium was not the basis of the intervention.

hAnalyses adjusted for age, clinical site, annual menses, and treatment assignment.

iAnalyses adjusted for age, height, weight, annual percentage change in weight, physical activity level, smoking status, socioeconomic status, and baseline femoral neck BMD.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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TABLE E-13 Randomized Controlled Trials Assessing the Effect of Sodium Intake on Type 2 Diabetes, Glucose, and Insulin Outcomes

Reference (Location) Participants Intervention(s) Control Duration Results
Parallel Study Design
Meland and Aamland, 2009 (Norway) 46 men and women, aged 20–75 years with uncontrolled hypertension Received NaCl capsules to equal 50 mmol/d and counseled to follow a moderate reduced-salt diet Received placebo capsules and counseled to follow a moderate reduced-salt diet 8 weeks No significant differences in changes of fasting and postload glucose and insulin C-peptide levels between low-salt (placebo) and high-salt (intervention) groups.
Crossover Study Design
Suckling et al., 2016 (United Kingdom) 46 men and women, aged 30–80 years with type 2 diabetes or impaired glucose tolerance Received salt tablets to equal 90 mmol/d and instructed to follow reduced salt diet of approximately 90 mmol/d Received placebo tablets and instructed to follow reduced salt diet of approximately 90 mmol/d 12 weeks No significant change in fasting glucose or insulin concentration observed from intervention to placebo period.

NOTE: mmol/d = millimoles per day; NaCl = sodium chloride.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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TABLE E-14 Prospective Cohort Study Assessing the Association Between Sodium Intake and Type 2 Diabetes, Glucose, and Insulin Outcomes

Reference (Location) Participantsa Length of Follow-Up Potassium Assessment Results
Hu et al., 2005 (Finland) 1,935 men and women aged 35–64 years 18.1 years Measured by one 24-hour urine sample at baseline Multiple-adjusted hazard ratio for diabetes for the highest versus combined lower quartiles of 24-hour urinary sodium excretion was 2.05 [95% CI: 1.43, 2.96].b

NOTE: CI = confidence interval.

aTotal number of participants included in the analysis.

bAnalyses adjusted for age, sex, study year, body mass index, physical activity, systolic blood pressure, antihypertensive drug treatment, education, smoking and coffee, alcohol, fruit, vegetable, sausage, bread, and saturated fat consumption.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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TABLE E-15 Randomized Controlled Trial Assessing the Effect of Potassium Intake Supplements on Type 2 Diabetes, Glucose, and Insulin Outcomes

Reference (Location) Participants Intervention(s) Control Duration Results
Chatterjee et al., 2017 (United States) 27 African American men and women with prediabetes Received 40 mmol/d KCl Received daily placebo capsules 12 weeks
  • KCl supplement reduced fasting glucose by 7.2 mg/dL (p = .03).
  • No significant differences in 2-hour postload glucose, insulin, or C-peptide.
  • No significant difference in insulin sensitivity indexes or hemoglobin A1c.

NOTE: KCl = potassium chloride; mg/d = milligrams per day; mmol/d = millimoles per day.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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TABLE E-16 Prospective Cohort Study Assessing the Association Between Potassium Intake and Type 2 Diabetes, Glucose, and Insulin Outcomes

Reference (Location) Participantsa Length of Follow-Up Potassium Assessment Results
Hu et al., 2005 (Finland) 1,935 men and women aged 35–64 years 18.1 years Measured by one 24-hour urine sample at baseline Potassium excretion was not associated with the risk of type 2 diabetes.
Chatterjee et al., 2010 (United States) 12,209 men and women, aged 45–65 at baseline 9 years Measured by FFQ at baseline Dietary potassium intake was not significantly associated with risk of incident diabetes in multivariable models.b
Chatterjee et al., 2012 (United States) 4,754 men and women, aged 18–30 years 20 years Dietary potassium measured by FFQ at baseline, year 7, and year 20; 3 consecutive 24-hour urines collected in subsample of 1,066 participants at year 5 In multivariable models, participants in the lowest urinary potassium quintile were more than twice as likely to develop diabetes as their counterparts in the highest quintile (HR = 2.45 [95% CI: 1.08, 5.59]).c

NOTE: CI = confidence interval; FFQ = food frequency questionnaire; HR = hazard ratio.

aTotal number of participants included in the analysis.

bAnalyses adjusted for age, sex, race, clinical center, body mass index, waist circumference, serum magnesium, calcium, and creatinine levels, physical activity, parental history of diabetes, presence of hypertension, systolic blood pressure, fasting glucose and insulin levels, income, and use of β-blockers, diuretics, and angiotensin-converting enzyme inhibitors.

cAnalyses adjusted for age, sex, race, body mass index, family history of diabetes, systolic blood pressure, physical activity level, education level, and the average of three 24-hour urinary creatinine measures.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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Assessing the Risk of Bias of Included Studies

To align with the AHRQ Systematic Review (Newberry et al., 2018), the committee assessed the risk of bias of each of the 14 references identified, using the same criteria used in the AHRQ Systematic Review (for criteria, see Appendix C, Annex C-1) (see Tables E-17 through E-20). The assessment was conducted by one reviewer, in line with principles of a rapid review.

TABLE E-17 Risk-of-Bias Assessment of Sodium Trials

Author, Year Random Sequence Generation Allocation Concealment Blinding of Participants and Personnel Blinding of Outcome Assessment Incomplete Outcome Data (Attrition Bias) Selective Reporting of Outcome Data Adherence Unequal Distribution Among Groups of Potential Confounders at Baseline
Meland and Aamland, 2009 Unclear risk Low risk Low risk Low risk Low risk Low risk Low risk Low risk
Suckling et al., 2016 Low risk Low risk Low risk Low risk Low risk Low risk Unclear risk Low risk

NOTE: BPUK = Blood Pressure U.K.; CASH = Consensus Action on Salt and Health; COI = conflict of interest; N/A = not applicable; WASH = World Action on Salt and Health.

a Neither author received funding from any of the organizations.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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Demonstration That Outcome of Interest Was Not Present at Start of Study for All Participants Valid Method of Exposure Assessment Valid Method of Outcome Assessment Valid Statistical Assessment (for Crossover Trials) Funding Source (Sponsor) Other: Funding Source (Author COI) Funding Source (Private Source) Overall Risk of Bias
Low risk Unclear risk Low risk N/A Public and private “The authors have no competing interests to declare.” N/A Low
Low risk Low risk Low risk Low risk Public FJ. He is a member of the CASH and WASH; G.A. MacGregor is Chairman of BPUK, CASH, WASH, and Action on Sugara N/A Low
Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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TABLE E-18 Risk-of-Bias Assessment for Sodium Observational Studies

Author, Year Representativeness of the Exposed Cohort Selection of the NonExposed Cohort Ascertainment of Sodium Exposure Outcome of Interest Not Present at Start of Study Comparability of Cohorts on the Basis of the Design or Analysis
Hu et al., 2005 Moderate risk Low risk High risk Low risk Low risk
Illich et al., 2010 Moderate risk Low risk Low risk Low risk Low risk

NOTE: COI = conflict of interest; N/A = not applicable; NR = not reported.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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Assessment of Outcome Adequacy of Follow-Up Funding Source (Sponsor) Funding Source (Author COI) Funding Source (Private Source) Overall Risk of Bias
Low risk High risk Public NR N/A High
Low risk High risk Public “The authors declare that they have no conflict of interest.” “Bayer HealthCare LLC, Morristown, NJ, USA” Moderate
Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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TABLE E-19 Risk-of-Bias Assessment of Potassium Trials

Author, Year Random Sequence Generation Allocation Concealment Blinding of Participants and Personnel Blinding of Outcome Assessment Incomplete Outcome Data (Attrition Bias) Selective Reporting of Outcome Data Adherence Unequal Distribution Among Groups of Potential Confounders at Baseline
Chatterjee et al., 2017 Low risk Low risk Low risk Low risk Low risk Low risk Low risk Low risk
Gregory et al., 2015 Low risk Low risk Low risk Low risk Unclear Low risk Low risk Moderate risk
Jehle et al., 2013 Unclear Unclear Low risk Low risk Low risk Low risk Low risk Low risk
Macdonald et al., 2008 Low risk Low risk Low risk Low risk Low risk Low risk Low risk Low risk

NOTE: COI = conflict of interest; N/A = not applicable; NR = not reported.

aIncluded statement of no involvement of the study.

bSLN and HMM correspond to initials of the publication authors.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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Demonstration That Outcome of Interest Was Not Present at Start of Study for All Participants Valid Method of Exposure Assessment Valid Method of Outcome Assessment Valid Statistical Assessment (for Crossover Trials) Funding Source (Sponsor) Other: Funding Source (Author COI) Funding Source (Private Source) Overall Risk of Bias
Low risk Low risk Low risk N/A Public NR N/A Low
Low risk Unclear Low risk N/A Public and private incorporationa NR N/A Low
Low risk Moderate risk Low risk N/A Public and private incorporationa “The authors have no conflicts of interest to report.” Yes Low
Low risk Low risk Low risk N/A Public SLN principal grant holder on a grant from GlaxoSmithKline to examine one of the company’s products; HMM involved in interpreting the results of that study; none of the other authors had personal or financial COIb N/A Low
Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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TABLE E-20 Risk-of-Bias Assessment for Potassium Observational Studies

Author, Year Representativeness of the Exposed Cohort Selection of the NonExposed Cohort Ascertainment of Potassium Exposure Outcome of Interest Not Present at Start of Study Comparability of Cohorts on the Basis of the Design or Analysis
Chatterjee et al., 2010 Moderate risk Low risk High risk Low risk Low risk
Chatterjee et al., 2012 Low risk Low risk Moderate risk Low risk Low risk
Hayhoe, 2015 Low risk Low risk Moderate risk Low risk Moderate risk
Hu et al., 2005 Moderate risk Low risk High risk Low risk Low risk
Macdonald et al., 2004 Low risk Low risk Moderate risk Low risk Moderate risk
Nieves et al., 2010 Low risk Low risk Moderate risk Low risk Moderate risk
Zhu et al., 2009 Low risk Low risk High risk Low risk Moderate risk

NOTE: COI = conflict of interest; N/A = not applicable.

aIncluded statement of no involvement of the study.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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Assessment of Outcome Adequacy of Follow-Up Funding Source (Sponsor) Funding Source (Author COI) Funding Source (Private Source) Overall Risk of Bias
Low risk Low risk Public None reported financial disclosure N/A High
Low risk Low risk Public “The authors declare that there is no duality of interest associated with this manuscript.” N/A Moderate
Low risk Unclear Public “None of the authors had a financial or personal conflict of interest relevant to this research at the time of writing.” N/A Moderate
Low risk High risk Public NR N/A High
Low risk Low risk Public “None of the authors had financial or commercial interest in any company or organization sponsoring the research.” N/A Moderate
Low risk Low risk Public and private incorporationa All authors claimed: nothing to disclose No Moderate
Low risk High risk Public “None reported conflict of interest.” N/A High
Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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UPDATE OF THE AHRQ SYSTEMATIC REVIEW

The AHRQ Systematic Review included evidence that was available as of March 2017. The AHRQ Systematic Review investigators extended the search to identify eligible publications published between March and December 2017, using the same literature search strategy and screening process that was used to identify the original collection of studies. The list of eligible publications was not included in the AHRQ Systematic Review, but it was provided to the committee (personal communication, S. Newberry, RAND Corporation, May 30, 2018). The committee further extended this search, based on the PubMed search strategy presented in the AHRQ Systematic Review, and it identified studies that met the inclusion criteria, published between December 2017 and June 2018. One additional study was provided to the committee via the public comment mechanism. Across these sources, 20 articles were identified as meeting the AHRQ Systematic Review inclusion criteria. Table E-21 provides a brief summary of the committee’s assessment of the applicability of each study to its evidence review.

TABLE E-21 References Identified as Meeting the AHRQ Systematic Review Inclusion Criteria, Published Between March 2017 and June 2018

Reference Notes About the Study
Lelli et al., 2018
  • High-risk-of-bias article based on AHRQ quality assessment criteria
  • High-risk-of-bias observational studies did not inform the committee’s decision making for the sodium CDRR for adults
Lelong et al., 2017
  • High-risk-of-bias article based on AHRQ quality assessment criteria
  • High-risk-of-bias observational studies did not inform the committee’s decision making for the sodium CDRR for adults
  • High-risk-of-bias observational studies did not inform the committee’s decision making related to blood pressure or incident hypertension for potassium CDRR for adults
Mente et al., 2018
  • High-risk-of-bias article based on AHRQ quality assessment criteria
  • High-risk-of-bias observational studies did not inform the committee’s decision making for the sodium or potassium CDRR for adults
Mirmiran et al., 2018
  • High-risk-of-bias article based on AHRQ quality assessment criteria
  • Used a food frequency questionnaire to assess dietary intake; evidence based on food frequency questionnaires was excluded from the sodium intake-related key questions, but was included in the potassium-related key questions
Pathak et al., 2017
  • Study conducted in patients with chronic kidney disease
  • Given insufficient evidence on effect modification of kidney disease, study did not inform the sodium DRIs
Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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Reference Notes About the Study
Prentice et al., 2017
  • High-risk-of-bias article based on AHRQ quality assessment criteria
  • Used a food frequency questionnaire to assess dietary intake; evidence based on food frequency questionnaires was excluded from the sodium intake-related key questions, but was included in the potassium-related key questions
Saran et al., 2017
  • Study conducted in patients with stage 3–4 chronic kidney disease
  • Given insufficient evidence on effect modification of kidney disease, study did not inform the sodium DRIs
Saulnier et al., 2017
  • Study conducted in individuals with type 2 diabetes
  • High-risk-of-bias article based on AHRQ quality assessment criteria
  • High-risk-of-bias observational studies did not inform the committee’s decision making for the sodium CDRR for adults
Setayeshgar et al., 2017
  • High-risk-of-bias article based on AHRQ quality assessment criteria
  • Study was part of a collection of evidence that informed the committee’s rationale regarding extrapolation of the sodium CDRR to children
Tabara et al., 2017
  • Study only reported on sodium-to-potassium ratio; independent relationship with sodium and potassium not reported
Torres et al., 2017
  • Study conducted in patients with autosomal dominant polycystic kidney disease
  • Given insufficient evidence on effect modification of kidney disease, study did not inform the sodium DRIs
Zhao et al., 2017
  • Study population was adults with suspected coronary heart disease, and therefore could not be used to estimate relationship with incident cardiovascular disease
Chen et al., 2016; Cheng et al., 2018; Juraschek et al., 2017; Murtaugh et al., 2018
  • Primary analyses of trials already included in the AHRQ Systematic Review
Allaert, 2017; Hu et al., 2018; Janda et al., 2018; Yang et al., 2018
  • Studies used salt substitutes; independent effects of sodium and potassium could not be determined
  • Studies did not inform the sodium or potassium DRIs

NOTE: AHRQ = Agency for Healthcare Research and Quality; CDRR = Chronic Disease Risk Reduction Intake; DRI = Dietary Reference Intake.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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REFERENCES

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Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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EFSA NDA Panel, D. Turck, J.-L. Bresson, B. Burlingame, T. Dean, S. Fairweather-Tait, M. Heinonen, K. I. Hirsch-Ernst, I. Mangelsdorf, H. McArdle, M. Neuhäuser-Berthold, G. Nowicka, K. Pentieva, Y. Sanz, A. Siani, A. Sjödin, M. Stern, D. Tomé, H. Van Loveren, M. Vinceti, P. Willatts, P. Aggett, A. Martin, H. Przyrembel, A. de Sesmaisons-Lecarré, S. V. Martinez, and A. Naska. 2018. Dietary reference values for sodium Draft-Jan 2018. https://www.efsa.europa.eu/sites/default/files/engage/170929_draft-opinion.pdf (accessed February 5, 2019).

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Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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Mirmiran, P., Z. Bahadoran, P. Nazeri, and F. Azizi. 2018. Dietary sodium to potassium ratio and the incidence of hypertension and cardiovascular disease: A population-based longitudinal study. Clinical and Experimental Hypertension 40(8):772-779.

Murtaugh, M. A., J. M. Beasley, L. J. Appel, P. M. Guenther, M. McFadden, T. Greene, and J. A. Tooze. 2018. Relationship of sodium intake and blood pressure varies with energy intake: Secondary analysis of the DASH (Dietary Approaches to Stop Hypertension)Sodium trial. Hypertension 71(5):858-865.

Newberry, S. J., M. Chung, C. A. M. Anderson, C. Chen, Z. Fu, A. Tang, N. Zhao, M. Booth, J. Marks, S. Hollands, A. Motala, J. K. Larkin, R. Shanman, and S. Hempel. 2018. Sodium and potassium intake: Effects on chronic disease outcomes and risks. Rockville, MD: Agency for Healthcare Research and Quality.

Nieves, J. W., K. Melsop, M. Curtis, J. L. Kelsey, L. K. Bachrach, G. Greendale, M. F. Sowers, and K. L. Sainani. 2010. Nutritional factors that influence change in bone density and stress fracture risk among young female cross-country runners. Physical Medicine & Rehabilitation 2(8):740-750; quiz 794.

Pathak, C. M., J. H. Ix, C. A. M. Anderson, T. B. Woodell, G. Smits, M. S. Persky, G. A. Block, and D. E. Rifkin. 2018. Variation in sodium intake and intra-individual change in blood pressure in chronic kidney disease. Journal of Renal Nutrition 28(2):125-128.

Peng, Y., G. C. Zhong, Q. Mi, K. Li, A. Wang, L. Li, H. Liu, and G. Yang. 2017. Potassium measurements and risk of type 2 diabetes: A dose-response meta-analysis of prospective cohort studies. Oncotarget 8(59):100603-100613.

Prentice, R. L., Y. Huang, M. L. Neuhouser, J. E. Manson, Y. Mossavar-Rahmani, F. Thomas, L. F. Tinker, M. Allison, K. C. Johnson, S. Wassertheil-Smoller, A. Seth, J. E. Rossouw, J. Shikany, L. D. Carbone, L. W. Martin, M. L. Stefanick, B. Haring, and L. Van Horn. 2017. Associations of biomarker-calibrated sodium and potassium intakes with cardiovascular disease risk among postmenopausal women. American Journal of Epidemiology 186(9):1035-1043.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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Saran, R., R. L. Padilla, B. W. Gillespie, M. Heung, S. L. Hummel, V. K. Derebail, B. Pitt, N. W. Levin, F. Zhu, S. R. Abbas, L. Liu, P. Kotanko, and P. Klemmer. 2017. A randomized crossover trial of dietary sodium restriction in stage 3-4 CKD. Clinical Journal of the American Society of Nephrology 12(3):399-407.

Saulnier, P. J., E. Gand, S. Ragot, L. Bankir, X. Piguel, F. Fumeron, V. Rigalleau, J. M. Halimi, R. Marechaud, R. Roussel, and S. Hadjadj. 2017. Urinary sodium concentration is an independent predictor of all-cause and cardiovascular mortality in a type 2 diabetes cohort population. Journal of Diabetes Research 2017:5327352.

Setayeshgar, S., J. P. Ekwaru, K. Maximova, S. R. Majumdar, K. E. Storey, J. McGavock, and P. J. Veugelers. 2017. Dietary intake and prospective changes in cardiometabolic risk factors in children and youth. Applied Physiology, Nutrition, and Metabolism. Physiologie Appliquée, Nutrition et Métabolisme 42(1):39-45.

Shea, B. J., B. C. Reeves, G. Wells, M. Thuku, C. Hamel, J. Moran, D. Moher, P. Tugwell, V. Welch, E. Kristjansson, and D. A. Henry. 2017. AMSTAR 2: A critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both. BMJ 358:j4008.

Suckling, R. J., J. Feng, N. D. Markandu, and G. A. MacGregor. 2016. Modest salt reduction lowers blood pressure and albumin excretion in impaired glucose tolerance and type 2 diabetes mellitus: A randomized double-blind trial. Hypertension 67(6):1189-1195.

Tabara, Y., Y. Takahashi, K. Setoh, T. Kawaguchi, S. Kosugi, T. Nakayama, and F. Matsuda. 2017. Prognostic significance of spot urine Na/K for longitudinal changes in blood pressure and renal function: The Nagahama study. American Journal of Hypertension 30(9):899-906.

Torres, V. E., K. Z. Abebe, R. W. Schrier, R. D. Perrone, A. B. Chapman, A. S. Yu, W. E. Braun, T. I. Steinman, G. Brosnahan, M. C. Hogan, F. F. Rahbari, J. J. Grantham, K. T. Bae, C. G. Moore, and M. F. Flessner. 2017. Dietary salt restriction is beneficial to the management of autosomal dominant polycystic kidney disease. Kidney International 91(2):493-500.

Whelton, P. 2018. Safety of sodium reduction and potassium supplementation in various populations. Presented at the March 7, 2018 Public Workshop of the Committee to Review the Dietary Reference Intakes for Sodium and Potassium, Washington, DC.

Yang, G. H., X. Zhou, W. J. Ji, J. X. Liu, J. Sun, R. Shi, T. M. Jiang, and Y. M. Li. 2018. Effects of a low salt diet on isolated systolic hypertension: A community-based population study. Medicine (Baltimore) 97(14):e0342.

Zhao, X., Y. Zhang, X. Zhang, Y. Kang, X. Tian, X. Wang, J. Peng, Z. Zhu, and Y. Han. 2017. Associations of urinary sodium and sodium to potassium ratio with hypertension prevalence and the risk of cardiovascular events in patients with prehypertension. Journal of Clinical Hypertension (Greenwich, Connecticut) 19(12):1231-1239.

Zhu, K., A. Devine, and R. L. Prince. 2009. The effects of high potassium consumption on bone mineral density in a prospective cohort study of elderly postmenopausal women. Osteoporosis International 20(2):335-340.

Suggested Citation:"Appendix E: Supplemental Literature Searches." National Academies of Sciences, Engineering, and Medicine. 2019. Dietary Reference Intakes for Sodium and Potassium. Washington, DC: The National Academies Press. doi: 10.17226/25353.
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Next: Appendix F: Estimates of Potassium and Sodium Intakes from Breast Milk and Complementary Foods »
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As essential nutrients, sodium and potassium contribute to the fundamentals of physiology and pathology of human health and disease. In clinical settings, these are two important blood electrolytes, are frequently measured and influence care decisions. Yet, blood electrolyte concentrations are usually not influenced by dietary intake, as kidney and hormone systems carefully regulate blood values.

Over the years, increasing evidence suggests that sodium and potassium intake patterns of children and adults influence long-term population health mostly through complex relationships among dietary intake, blood pressure and cardiovascular health. The public health importance of understanding these relationships, based upon the best available evidence and establishing recommendations to support the development of population clinical practice guidelines and medical care of patients is clear.

This report reviews evidence on the relationship between sodium and potassium intakes and indicators of adequacy, toxicity, and chronic disease. It updates the Dietary Reference Intakes (DRIs) using an expanded DRI model that includes consideration of chronic disease endpoints, and outlines research gaps to address the uncertainties identified in the process of deriving the reference values and evaluating public health implications.

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