Effects of Vitamin D3 Supplementation on Body Composition in the VITamin D and OmegA-3 TriaL (VITAL)

J Clin Endocrinol Metab. 2021 Apr 23;106(5):1377-1388. doi: 10.1210/clinem/dgaa981.


Context: Although observational studies show inverse associations between vitamin D status and body weight/adiposity, there are few large randomized controlled trials (RCTs) investigating this relationship.

Objective: To determine whether vitamin D3 supplementation lowers weight or improves body composition.

Design: The VITamin D and OmegA-3 TriaL (VITAL) was a double-blinded, placebo-controlled RCT including 25 871 US adults. This ancillary study was completed in a sub-cohort that underwent body composition assessments at baseline and 2-year follow-up (89% retention).

Setting: Harvard Clinical and Translational Science Center in Boston.

Participants: 771 participants (men ≥ 50 and women ≥ 55 years).

Interventions: 2 × 2 factorial design of supplemental vitamin D3 (2000 IU/day) and/or omega-3 fatty acids (1 g/day).

Main outcome measures: Endpoints were 2-year changes in weight, body mass index (BMI), waist circumference, and total and/or regional fat and lean tissue measures determined by dual-energy X-ray absorptiometry. Effect modification by clinical variables and total and free 25-hydroxyvitamin D (25[OH]D) levels was explored.

Results: There were no effects of supplemental vitamin D3vs placebo on weight, BMI, or measures of adiposity and lean tissue. Effects did not vary by sex, race/ethnicity, fat mass index, or baseline total or free 25(OH)D levels. Vitamin D3 supplementation did slightly improve body fat percentage in participants with normal BMI at baseline, but not in the overweight or obese (P for interaction = 0.04).

Conclusions: Daily vitamin D3 supplementation vs placebo in the general older population did not improve weight or body composition. Whether supplemental vitamin D3 may benefit individuals with normal BMI warrants further study.

Trial registration: ClinicalTrials.gov NCT01747447 NCT01169259 NCT01704859.

Keywords: adiposity; body composition; body mass index; lean tissue; vitamin D; weight.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adiposity / drug effects
  • Adult
  • Aged
  • Body Composition / drug effects*
  • Body Mass Index
  • Bone Density / drug effects
  • Cardiovascular Diseases / epidemiology
  • Cardiovascular Diseases / prevention & control
  • Cholecalciferol / administration & dosage
  • Cholecalciferol / pharmacology*
  • Cohort Studies
  • Dietary Supplements
  • Double-Blind Method
  • Fatty Acids, Omega-3 / administration & dosage
  • Female
  • Follow-Up Studies
  • Heart Disease Risk Factors
  • Humans
  • Male
  • Middle Aged
  • Neoplasms / epidemiology
  • Neoplasms / prevention & control
  • Obesity / diet therapy
  • Obesity / epidemiology
  • Overweight / diet therapy
  • Overweight / epidemiology
  • United States / epidemiology


  • Fatty Acids, Omega-3
  • Cholecalciferol

Associated data

  • ClinicalTrials.gov/NCT01747447
  • ClinicalTrials.gov/NCT01169259
  • ClinicalTrials.gov/NCT01704859