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

Authors: BISCHOFF-FERRARI, HEIKE - University Of Zurich; FREYSTATTER, GREGOR - University Of Zurich; VELLAS, BRUNO - Gerontopole De Toulouse Center Hospital University; DAWSON-HUGHES, BESS - Jean Mayer Human Nutrition Research Center On Aging At Tufts University; KRESSIG, RETO - University Of Basel; KANIS, JOHN - University Of Sheffield; WILLETT, WALTER - Harvard School Of Public Health; MANSON, JOANN - Brigham & Women'S Hospital; RIZZOLI, RENE - Geneva University Hospital; THEILER, ROBERT - University Of Zurich; HOFBAUER, LORENZ - Dresden University; AMBRECHT, GABRIELE - Berlin Free University; DA SILVA, JOSE A.P. - University Of Coimbra; BLAUTH, MICHAEL - Innsbruck Medical University; DE GODOI REZENDE, CAROLINE - University Hospital Zurich; LANG, WEI - University Of Zurich; SIEBERT, UWE - Harvard Medical School; EGLI, ANDREAS - University Of Zurich; ORAV, E. JOHN - Harvard University; WIECZOREK, MAUD - University Of Zurich

Submitted to: Lancet
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 1/24/2022
Publication Date: 5/1/2022
Citation: Bischoff-Ferrari, H.A., Freystatter, G., Vellas, B., Dawson-Hughes, B., Kressig, R.W., Kanis, J.A., Willett, W.C., Manson, J.E., Rizzoli, R., Theiler, R., Hofbauer, L., Ambrecht, G., Da Silva, J., Blauth, M., De Godoi Rezende, C., Lang, W., Siebert, U., Egli, A., Orav, E., Wieczorek, M. 2022. Effects of vitamin D, omega-3 fatty acids and a simple home strength exercise program on fall prevention: the DO-HEALTH randomized clinical trial. Lancet. https://doi.org/10.1093/ajcn/nqac022.
DOI: https://doi.org/10.1093/ajcn/nqac022

Interpretive Summary: The number of older adults with age-related chronic diseases is increasing and interventions that are effective, affordable, and well-tolerated in the prevention of chronic conditions are urgently needed. The DO-HEALTH study is a multi-center clinical trial conducted in 2,157 community-dwelling men and women, age 70 and older, at 5 clinical sites in Europe. The trial tested the individual and additive benefits of 3 interventions: vitamin D 2,000 IU/day, omega-3 fatty acids 1,000 mg/day, and a 30-minute 3 times/week home exercise program on several chronic conditions including falls. A total of 3,333 falls occurred during the study. The main finding from this analysis is that supplementation with 1 gram per day of marine omega-3 fatty acids resulted in a significant 10% reduction in the total number of falls and an 11% reduction in injurious falls during the study. In contrast, neither vitamin D supplementation nor the home- based exercise program had a significant effect of risk of falling. These findings require replication but may be relevant at the public health level.

Technical 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. METHODS: We performed a 2x2x2 factorial design randomized-controlled trial among 2157 community-dwelling adults age 70 years and older, recruited from Switzerland, Germany, Austria, France, and Portugal between December 2012 and November 2014. Participants were randomly assigned to 2000 IU/day of vitamin D3 and / or 1 g/day of marine omega-3s, and / or a simple home strength exercise program (SHEP) versus placebo and / or control exercise over 3 years, and had no major health events in the five years prior to enrolment. For this manuscript, the primary endpoint was the incidence rate of total falls. The secondary fall endpoint was the incidence rate of injurious falls. Falls were recorded prospectively throughout the trial. Since there were no interactions between treatments, main effects are reported based on intent-to-treat. FINDINGS: Among 2157 randomized participants (mean age 74.9 years; 61.7% women; 40.7% had 25(OH)D < 20 ng/ml, 83% at least moderately physically active), 3333 falls were recorded over a median follow-up of 2.99 years. Vitamin D and SHEP had no benefit on total or injurious falls, whilst omega-3s compared to no omega-3s reduced total falls by 10% (incidence rate ratio IRR = 0.90, 95% CI [0.81, 1.00], p = 0.04). This benefit was consistent in subgroups by sex, age, prior faller status, including physically active participants at baseline (IRR=0.84, 95% CI [0.72, 0.97]); and extended to injurious falls (IRR = 0.91, 95% CI [0.81, 1.01]), including physically active participants (IRR=0.81, 95% CI [0.70, 0.95]). INTERPRETATION: Among generally healthy, active and largely vitamin D replete older adults, supplemental omega-3s reduced falls modestly, whilst daily high-dose vitamin D or SHEP had no benefit.