Effects of Vitamin D, Omega-3 Fatty Acids and a Home Exercise Program on Prevention of Pre-Frailty in Older Adults: The DO-HEALTH Randomized Clinical Trial.
Level 2 - randomized trial
Multi-center, double-blind, placebo-controlled 2x2x2 factorial randomized clinical trial
PubMed 36629088 · doi:10.14283/jfa.2022.48
What was done
Secondary analysis of 1,137 robust European adults aged 70 or older (mean age 74.3 years, 56.5% women) from the DO-HEALTH multi-center, double-blind, placebo-controlled 2x2x2 factorial randomized clinical trial. Participants received supplemental 2,000 IU/day vitamin D3, 1 g/day marine omega-3s, and a simple home exercise program (SHEP), individually or in combination, versus control/placebo over a median follow-up of 2.9 years (36 months) to evaluate incident pre-frailty and frailty.
What was found
Over follow-up, 696 participants (61.2%) became pre-frail and 29 (2.6%) became frail. Odds ratios for incident pre-frailty were not significantly reduced by vitamin D3, omega-3s, or SHEP individually compared to control. The three treatments combined significantly reduced the odds of becoming pre-frail (OR 0.61, 95% CI 0.38-0.98, p=0.04). Neither individual treatments nor their combination significantly reduced the odds of becoming frail.
Why it matters
In robust, healthy older adults, combining vitamin D3, marine omega-3s, and a home exercise program may help prevent progression to pre-frailty, whereas single-component interventions showed no clear benefit.
Limits
This was a secondary outcome analysis of a subgroup (1,137 of 2,157 trial participants). The population was limited to generally healthy, cognitively intact European older adults without major comorbidities or recent major health events. With only 29 incident frailty events, the study was underpowered to detect effects on overt frailty.