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

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.

Baseline Levels of Vitamin D in a Healthy Population from a Region with High Solar Irradiation

“…Results showed no effect on BMD after 2 years of VitD supplementation either in the whole population or in subgroups defined by baseline 25(OH)D levels <15 ng/mL vs. >15 ng/mL or even at <10 ng/mL vs. >10 ng/mL [ 14 ]. Similar negative results regarding the benefit of VitD supplementation (in the entire population or in the same subgroups of baseline 25(OH)D) in the risk of falls were provided by the VITAL trial [ 53 ]. The role of VitD supplementation on non-vertebral fractures and falls was analyzed both as secondary and post hoc outcomes in the VIDA trial, a randomized placebo-controlled study that included more than 5000 men and women older than 50 years [ 54 ].…”

“…Given the evidence supporting that VitD supplementation in adult individuals with baseline 25(OH)D levels <15 ng/mL does not result in improved musculoskeletal health [ 13 , 14 , 53 ], and the fact that a causal relationship of VitD with numerous non-skeletal diseases has not yet been demonstrated [ 24 , 25 , 31 , 62 ], and in light of the distribution of the concentration of this vitamin in healthy adults living under optimal conditions of solar irradiation, it seems reasonable to consider 25(OH)D levels below 20 ng/mL and close to 15 ng/mL as optimal, at least for the general population of European origin.…”

Is There Proof of Extraskeletal Benefits From Vitamin D Supplementation From Recent Mega Trials of Vitamin D?

“…Recent results from the VITAL study are confirmatory, with no effect from vitamin D on the odds of having two or more falls during follow-up seen in the total sample or in participants with baseline 25(OH)D ≤30 nmol/L ( Table 2). (56) The evidence from these two studies strongly suggests that vitamin D supplementation by itself does not prevent falls among people dwelling in the community, even in people who are vitamin D deficient. Other current mega trials-CAPS, DO-HEALTH, TIPS-3, and D-Health-have falls as a secondary outcome (Supplemental Table S1), whereas the DO-HEALTH study has recently reported that vitamin D does not improve the Short Physical Performance Battery score.…”

Pinpointing a Role for Vitamin D in Frailty: A Time for Animal Models?

“…This was a modest dose, and 25-OH vitamin D levels were not assessed. Two recent prospective trials investigated whether vitamin D supplementation reduces falls or improves physical performance and found no benefit [ 22 , 23 ]. In contrast, a systematic review concluded that vitamin D improved muscle mass and physical performance in older women [ 24 ].…”