Bischoff-Ferrari · The American journal of clinical nutrition 2022 · 2x2x2 factorial randomized controlled trial · n=2157

Effects of vitamin D, omega-3 fatty acids, and a simple home strength exercise program on fall prevention: the DO-HEALTH randomized clinical trial.

Cited 40 times in the scientific literature.

Level 2 - randomized trial

Individual randomized controlled trial with 2x2x2 factorial design

PubMed 35136915 · doi:10.1093/ajcn/nqac022 · record verified 2026-08-29

What was done

The DO-HEALTH trial was a 2 × 2 × 2 factorial randomized controlled trial conducted across five European countries (Switzerland, Germany, Austria, France, Portugal) in 2,157 community-dwelling adults aged 70 and older without major health events in the prior 5 years. Participants were randomly assigned for 3 years to daily vitamin D3 (2,000 IU/day), daily marine omega-3 fatty acids (1 g/day), a simple home exercise program (SHEP), or their respective placebos/control exercise. The primary endpoint analyzed was the incidence rate of prospectively recorded total falls over follow-up, evaluated using a modified intent-to-treat analysis.

What was found

A total of 1,900 participants (88%) completed the study (mean age 74.9 years, 61.7% female, 40.7% with baseline 25-hydroxyvitamin D < 20 ng/ml, 83% moderately physically active). Over a median follow-up of 2.99 years, 3,333 falls were recorded. There were no treatment interactions. Neither vitamin D3 nor the SHEP reduced total fall incidence. Omega-3 supplementation reduced total falls by 10% compared to no omega-3s (incidence rate ratio = 0.90; 95% CI, 0.81-1.00; P = 0.04).

Why it matters

In generally healthy and active older adults, routine high-dose vitamin D supplementation and basic home exercise do not lower fall rates, whereas omega-3 fatty acid supplementation provides a modest preventive benefit.

Limits

The cohort was predominantly healthy and active (83% at least moderately active with no major health events in the preceding 5 years), limiting generalizability to frailer, institutionalized, or high-fall-risk populations. The reduction in falls with omega-3 fatty acids was borderline statistically significant (upper 95% CI touched 1.00, P = 0.04). Specific fall subcategories (such as injurious falls) and adherence rates were not reported with numerical outcomes in the abstract.

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