Abstract
BACKGROUND: The role of vitamin D, omega-3 fatty acids and home exercise on fall prevention among generally healthy and active older adults is unclear.
OBJECTIVES: To test the effect of daily supplemental vitamin D, marine omega-3 s fatty acids and a simple home exercise program (SHEP), alone or in combination, on the incidence of total and injurious falls among generally healthy older adults.
METHODS: We performed a 2 × 2 × 2 factorial design randomized-controlled trial among 2157 community-dwelling adults age 70 years and older, who had no major health events in the five years prior to enrolment, recruited from Switzerland, Germany, Austria, France, and Portugal between December 2012 and November 2014. Participants were randomly assigned to 2000 international units/day of vitamin D3 and/or 1 g/day of marine omega-3 s, and/or a SHEP versus placebo and/or control exercise over three years. The primary endpoint for the present fall analysis was the incidence rate of total falls. Falls were recorded prospectively throughout the trial. Since there were no interactions between treatments, main effects are reported based on modified intent-to-treat.
RESULTS: Of 2157 randomized participants, 1900 (88%) completed the study. The mean age was 74.9 years, 61.7% were women, 40.7% had serum 25-hydroxyvitamin D concentration < 20 ng/ml, and 83% were at least moderately physically active. In total, 3333 falls were recorded over a median follow-up of 2.99 years. Overall, vitamin D and SHEP had no benefit on total falls, whilst omega-3 s compared to no omega-3 s reduced total falls by 10% (incidence rate ratio [IRR] = 0.90, 95% confidence interval [0.81, 1.00], P = 0.04).
CONCLUSION: Among generally healthy, active and vitamin D-replete older adults, supplemental omega-3 s may have a modest benefit on the incidence of total falls, whilst daily high-dose vitamin D or SHEP had no benefit. Trial registration number: NCT01745263 URL of registration: https://clinicaltrials.gov/ct2/show/NCT01745263.