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F
Evidence Maps

As part of the committee’s approach to the evaluation of data, evidence maps were developed to assist the committee in organizing its review of the available evidence for each indicator of interest. No effort was made to “fine tune” these maps, but rather they were an initial tool used by the committee to quickly summarize the nature of the available data. The evidence maps below show the evidence from mechanistic and animal data, observational studies, and randomized controlled trials (RCTs). In its evaluation of RCT evidence, the committee considered the study design and whether an indicator was pre-specified as a primary or secondary outcome. Overall, the committee evaluated individual studies and when needed, took methodological differences into account when categorizing a study for inclusion in the evidence maps. However the committee acknowledges the variability in the quality of studies within and across categories, and relied on its expert judgment and a detailed evaluation of each study when drawing conclusions about the relevance and application of an indicator to further consideration in the DRI process. Chapter 4 provides detailed text on each of the key studies that were considered by the committee for the selection of an indicator.



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F Evidence Maps As part of the committee’s approach to the evaluation of data, evidence maps were developed to assist the committee in organizing its review of the available evidence for each indicator of interest. No effort was made to “fine tune” these maps, but rather they were an initial tool used by the committee to quickly summarize the nature of the available data. The evi- dence maps below show the evidence from mechanistic and animal data, observational studies, and randomized controlled trials (RCTs). In its evalu- ation of RCT evidence, the committee considered the study design and whether an indicator was pre-specified as a primary or secondary outcome. Overall, the committee evaluated individual studies and when needed, took methodological differences into account when categorizing a study for inclusion in the evidence maps. However the committee acknowledges the variability in the quality of studies within and across categories, and relied on its expert judgment and a detailed evaluation of each study when drawing conclusions about the relevance and application of an indicator to further consideration in the DRI process. Chapter 4 provides detailed text on each of the key studies that were considered by the committee for the selection of an indicator. 1019

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1020 DIETARY REFERENCE INTAKES FOR CALCIUM AND VITAMIN D TABLE F-1 Evidence Map for Cancer/Neoplasms Randomized Trials Secondary or Non– Mechanistic Animal Observational Primary Pre-specified Outcomesa Indicator Data Data Studies Outcome Calcium ✓b ✓b All cancers ✓ ✓ ✓ Breast cancer — — — — ✓ ✓b ✓b Colorectal cancer ✓ ✓ ✓ Colorectal adenoma — ✓ ✓ ✓ ✓ Prostate cancer — — — ✓ ✓ Vitamin D ✓b All cancers — ✓ ✓ ✓ ✓b Breast cancer — — — ✓ ✓b Colorectal cancer — ✓ ✓ ✓ ✓b Colorectal adenoma — ✓ ✓ ✓ Prostate cancer — — — — ✓ NOTE: ✓ = evidence is published; — = no available evidence. aSecondary outcomes often were not pre-specified by the investigators. bLimited data. TABLE F-2 Evidence Map for Cardiovascular Diseases (CVD)/ Hypertension Randomized Trials Secondary or Non– Mechanistic Animal Observational Primary Pre-specified Outcomea Indicator Data Data Studies Outcome ✓b Calcium — ✓ ✓ ✓ ✓b Vitamin D — ✓ ✓ ✓ NOTE: ✓ = evidence is published; — = no available evidence. aSecondary outcomes often were not pre-specified by the investigators. bLimited data. TABLE F-3 Evidence Map for Diabetes (Type 2) and Metabolic Syndrome Randomized Trials Secondary or Non– Mechanistic Animal Observational Primary Pre–specified Outcomesa Indicator Data Data Studies Outcome Vitamin D ✓ ✓ ✓ ✓ ✓ NOTE: ✓ = evidence is published; — = no available evidence. aSecondary outcomes often were not pre-specified by the investigators.

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1021 APPENDIX F TABLE F-4 Evidence Map for Falls and Physical Performance Randomized Trials Secondary or Non– Mechanistic Animal Observational Primary Pre-specified Outcomesa Indicator Data Data Studies Outcome Calcium ✓ ✓ ✓ ✓ ✓ Vitamin D ✓ ✓ ✓ ✓ ✓ NOTE: ✓ = evidence is published; — = no available evidence. aSecondary outcomes often were not pre-specified by the investigators. TABLE F-5 Evidence Map for Immune Function Randomized Trials Secondary or Non– Mechanistic Animal Observational Primary Pre-specified Outcomesa Indicator Data Data Studies Outcome Vitamin D Asthma — — ✓ ✓ ✓ Diabetes (Type 1) — — ✓ ✓ ✓ Irritable bowel and — — ✓ ✓ ✓ crohn’s disease Multiple sclerosis — — ✓ ✓ ✓ Rheumatoid — — — ✓ ✓ arthritis Systemic lupus — — ✓ ✓ ✓ erythematosus Tuberculosis ✓ ✓ ✓ ✓ ✓ Influenza/ — ✓ ✓ ✓ ✓ Upper respiratory infections NOTE: ✓ = evidence is published; — = no available evidence. aSecondary outcomes often were not pre-specified by the investigators.

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1022 DIETARY REFERENCE INTAKES FOR CALCIUM AND VITAMIN D TABLE F-6 Evidence Map for Neuropsychological Functioning Randomized Trials Secondary or Non– Mechanistic Animal Observational Primary Pre-specified Outcomesa Indicator Data Data Studies Outcome Vitamin D Autism — — ✓ ✓ ✓ Cognitive — — ✓ ✓ ✓ Function Depression ✓ — — ✓ ✓ NOTE: ✓ = evidence is published; — = no available evidence. aSecondary outcomes often were not prespecified by the investigators. TABLE F-7 Evidence Map for Preeclampsia of Pregnancy Randomized Trials Secondary or Non– Mechanistic Animal Observational Primary Pre-specified Outcomesa Indicator Data Data Studies Outcome Calcium — — ✓ ✓ ✓ Vitamin D — — — — ✓ NOTE: ✓ = evidence is published; — = no available evidence. aSecondary outcomes often were not pre-specified by the investigators.

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1023 APPENDIX F TABLE F-8 Evidence Map for Bone Health Randomized Trials Secondary or Non– Mechanistic Animal Observational Primary Pre-specified Outcomesa Indicator Data Data Studies Outcome Calcium absorption ✓ ✓ ✓ ✓ ✓ Calcium balance ✓ ✓ ✓ ✓ ✓ BMD/BMC ✓ ✓ ✓ ✓ ✓ Fracture risk ✓ ✓ ✓ ✓ ✓ Osteomalacia/ ✓ ✓ ✓ ✓ ✓ rickets Randomized Trials Secondary or Non– Mechanistic Animal Observational Primary Pre-specified Outcomesa Intermediate Data Data Studies Outcome 25OHD ✓ ✓ ✓ ✓ ✓ PTH ✓ ✓ ✓ ✓ ✓ NOTE: Data may reflect studies designed to study combined calcium and vitamin D admin- istration, calcium alone, or vitamin D alone. ✓ = evidence is published; — = no available evidence. aSecondary outcomes often were not pre-specified by the investigators.

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