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The Effect of Vitamin D3 Supplementation on the Risk of Falls in a General Population-The Finnish Vitamin D Trial.

  • 2026-01-13
  • Journal of the American Geriatrics Society 74(6)
    • Toni Rikkonen
    • Sari Hantunen
    • Heikki Kröger
    • Christel Lamberg-Allardt
    • JoAnn E Manson
    • Tarja Nurmi
    • Marjo Tuppurainen
    • Ari Voutilainen
    • Tomi-Pekka Tuomainen
    • Jyrki K Virtanen

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 2,495
Population
2495 generally healthy, community-dwelling men (≥60) and women (≥65) in Finland
Methods
Randomized, double-blind, placebo-controlled trial, 5 years of vitamin D3 1600 IU/day or 3200 IU/day vs placebo, falls collected via questionnaires at months 0, 12, 24, 36, and 60
Blinding
Double-blind
Duration
5 years
Funding
Unclear
  • Large Human Trial

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/ct2/show/NCT01463813.

Research Insights

  • Vitamin D3→Reduced Fall Injury Risk

    Five-year vitamin D3 supplementation of 1600 IU/day or 3200 IU/day did not affect the overall risk of fall injuries

    Effect
    Neutral
    Effect size
    Small
    Dose
    1600 IU/day or 3200 IU/day
  • Vitamin D3→Reduced Fall Risk

    Five-year vitamin D3 supplementation of 1600 IU/day or 3200 IU/day did not affect the overall risk of falls

    Effect
    Neutral
    Effect size
    Small
    Dose
    1600 IU/day or 3200 IU/day
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