ABSTRACT
Background
The impact of vitamin D on fall incidence remains controversial. We studied the effect of 5 years of vitamin D3 supplementation on the risk of falls in a double-blind, placebo-controlled randomized trial with generally healthy, community-dwelling men and women in Finland.
Methods
The study included 2495 participants, men aged ≥ 60 and women aged ≥ 65, who were randomized into three arms: 1600 IU/day or 3200 IU/day of vitamin D3 or placebo. A random subgroup of 551 participants underwent more detailed examinations. Falls and fall-related injuries were collected with questionnaires at months 0, 12, 24, 36, and 60. General linear mixed models and generalized linear models were used for analyses.
Results
Over the 5-year follow-up, a similar fall risk of 55% and fall-injury risk of 11% were observed in the placebo, 1600 IU/day, and 3200 IU/day arms, with the mean number of falls and fall-injuries per person-year of 1.26 (95% CI 1.14–1.38) and 0.07 (95% CI 0.06–0.08), respectively. Age, sex, or BMI did not modify the results. In the random subgroup, the mean baseline serum 25(OH)D concentration was 75 nmol/L (SD 18). After 12 months, the concentrations were 73, 100, and 120 nmol/L in the placebo, 1600 IU/day, and 3200 IU/day arms, respectively.
Conclusions
Five-year vitamin D3 supplementation of 1600 IU/day or 3200 IU/day did not affect the overall risk of falls or fall injuries among generally healthy, largely vitamin D sufficient men and women. The findings do not support the use of high vitamin D doses for fall prevention in such populations.
Trial Registration
ClinicalTrials.gov: NCT01463813, https://clinicaltrials.gov/study/NCT01463813