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
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
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]).
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 |
|
| 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 |
|
| 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 |
|
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.
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 |
|
| Zhu et al., 2009 (Australia) | 266 healthy women, 70–80 years of agec | 5 yearsd | One 24-hour urine assessment, conducted at baseline |
|
| 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 |
|
| 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 |
|
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.
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.
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.
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.
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 |
|
NOTE: KCl = potassium chloride; mg/d = milligrams per day; mmol/d = millimoles per day.
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.
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.
| 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 |
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.
| 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 |
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.
| 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 |
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.
| 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 |
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 |
|
| Lelong et al., 2017 |
|
| Mente et al., 2018 |
|
| Mirmiran et al., 2018 |
|
| Pathak et al., 2017 |
|
| Reference | Notes About the Study |
|---|---|
| Prentice et al., 2017 |
|
| Saran et al., 2017 |
|
| Saulnier et al., 2017 |
|
| Setayeshgar et al., 2017 |
|
| Tabara et al., 2017 |
|
| Torres et al., 2017 |
|
| Zhao et al., 2017 |
|
| Chen et al., 2016; Cheng et al., 2018; Juraschek et al., 2017; Murtaugh et al., 2018 |
|
| Allaert, 2017; Hu et al., 2018; Janda et al., 2018; Yang et al., 2018 |
|
NOTE: AHRQ = Agency for Healthcare Research and Quality; CDRR = Chronic Disease Risk Reduction Intake; DRI = Dietary Reference Intake.
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