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Randomized Controlled Trial
. 2020 Sep 1;105(9):2929-2938.
doi: 10.1210/clinem/dgaa311.

VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population

Meryl S LeBoff  1   2 , Elle M Murata  1 , Nancy R Cook  2   3   4 , Peggy Cawthon  5 , Sharon H Chou  1   2 , Gregory Kotler  3 , Vadim Bubes  3 , Julie E Buring  2   3   4 , JoAnn E Manson  2   3   4
Affiliations
Randomized Controlled Trial

VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population

Meryl S LeBoff et al. J Clin Endocrinol Metab. .

Abstract

Context: It is unclear whether vitamin D supplementation reduces risk of falls, and results from randomized controlled trials (RCTs) are conflicting.

Objective: The objective of this work is to determine whether 2000 IU/day of supplemental vitamin D3 decreases fall risk.

Design: VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, placebo-controlled RCT including 25 871 adults, randomly assigned November 2011 to March 2014 and treated for 5.3 years (median).

Setting: This is a nationwide study.

Participants: Men 50 years or older and women 55 years or older (mean age, 67.1 years) without cancer or cardiovascular disease at baseline participated in this study.

Interventions: Interventions included vitamin D3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (1 g/day) or respective placebos in a 2 × 2 factorial design.

Main outcome measures: Main outcome measures include 2 or more falls and falls resulting in a doctor or hospital visit.

Results: Baseline serum total 25-hydroxyvitamin D (25[OH]D) level was 77 nmol/L; characteristics were well-balanced between groups. Numbers of participants with 2 or more falls were similar between active and placebo groups (9.8% vs 9.4%). Over 5 years, there were no differences in the proportion having 2 or more falls (odds ratio [OR] = 0.97; 95% CI, 0.90-1.05, P = .50), falls resulting in a doctor visit (OR = 1.03; 95% CI, 0.94-1.13, P = .46), or resulting in a hospital visit (OR = 1.04; 95% CI, 0.90-1.19, P = .61) between groups. Results did not differ between those with baseline 25(OH)D less than 50 vs 50 nmol/L or greater or other cut points.

Conclusion: Daily supplemental vitamin D3 vs placebo did not decrease fall risk in generally healthy adults not selected for vitamin D insufficiency. This large RCT does not indicate that supplemental vitamin D should be used for primary prevention of falls in the US population.

Trial registration: ClinicalTrials.gov NCT01747447 NCT01704859.

Keywords: falls; primary prevention; vitamin D.

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Figures

Figure 1.
Figure 1.
Fall outcomes over 5 years according to random assignment to vitamin D or placebo groups.
Figure 2.
Figure 2.
Percentage of falls resulting in a hospital visit, in those with baseline free 25-hydroxyvitamin D above and below the median (14.75 pmol/L).
See this image and copyright information in PMC

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