Heike A Bischoff-Ferrari1,2,3, Gregor Freystätter1,2,3, Bruno Vellas4,5, Bess Dawson-Hughes6, Reto W Kressig7, John A Kanis8,9, Walter C Willett10, JoAnn E Manson11, René Rizzoli12, Robert Theiler1,2, Lorenz C Hofbauer13,14, Gabriele Armbrecht15, José A P da Silva16,17, Michael Blauth18, Caroline de Godoi Rezende Costa Molino1,2, Wei Lang1,2, Uwe Siebert19,20,21, Andreas Egli1,2, Endel J Orav22, Maud Wieczorek1,2. 1. Centre on Aging and Mobility, University of Zurich and City Hospital Zurich, Waid, Zurich, Switzerland. 2. Department of Aging Medicine and Aging Research, University of Zurich and University Hospital, Zurich, Switzerland. 3. University Clinic for Aging Medicine, City Hospital Zurich, Waid, Zurich, Switzerland. 4. Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France. 5. UMR INSERM 1027, University of Toulouse III, Toulouse, France. 6. Jean Mayer USDA Human Nutrition Research Centre on Aging, Tufts University, Boston, MA, USA. 7. University Department of Geriatric Medicine FELIX PLATTER, and University of Basel, Basel, Switzerland. 8. Centre for Metabolic Diseases, University of Sheffield Medical School, Sheffield, United Kingdom. 9. Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, Australia. 10. Department of Epidemiology and Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA. 11. Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. 12. Division of Bone Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland. 13. Centre for Healthy Aging, Department of Medicine III Dresden University Medical Centre, Dresden, Germany. 14. Centre for Regenerative Therapies Dresden, Technische Universität Dresden, Dresden, Germany. 15. Klinik für Radiologie, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany. 16. Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal. 17. Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal. 18. Department for Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria. 19. Department of Public Health, Health Services Research and Health Technology Assessment, UMIT-University for Health Sciences, Medical Informatics and Technology, Hall i.T., Austria. 20. Center for Health Decision Science, Departments of Epidemiology and Health Policy & Management, Harvard T.H. Chan School of Public Health, Boston, MA, USA. 21. Program on Cardiovascular Research, Institute for Technology Assessment and Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. 22. Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Abstract
BACKGROUND: The roles of vitamin D, omega-3 fatty acids, and home exercise on fall prevention among generally healthy and active older adults are unclear. OBJECTIVES: We tested the effects of daily supplemental vitamin D, daily supplemental marine omega-3s fatty acids, and a simple home exercise program (SHEP), alone or in combination, on the incidences 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 aged 70 years and older, who had no major health events in the 5 years prior to enrolment, recruited from Switzerland, Germany, Austria, France, and Portugal between December 2012 and November 2014. Participants were randomly assigned to supplementation with 2000 international units/day of vitamin D3 and/or 1 g/day of marine omega-3s, and/or a SHEP compared with placebo and/or control exercise over 3 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, the main effects are reported based on a modified intent-to-treat analysis. RESULTS: Of 2157 randomized participants, 1900 (88%) completed the study. The mean age was 74.9 years, 61.7% were women, 40.7% had a 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 the SHEP had no benefit on total falls, whilst supplementation with omega-3s compared to no omega-3 supplementation reduced total falls by 10% (incidence rate ratio = 0.90; 95% CI, 0.81-1.00; P = 0.04). CONCLUSIONS: Among generally healthy, active, and vitamin D-replete older adults, omega-3 supplementation may have a modest benefit on the incidence of total falls, whilst a daily high dose of vitamin D or a SHEP had no benefit.
BACKGROUND: The roles of vitamin D, omega-3 fatty acids, and home exercise on fall prevention among generally healthy and active older adults are unclear. OBJECTIVES: We tested the effects of daily supplemental vitamin D, daily supplemental marine omega-3s fatty acids, and a simple home exercise program (SHEP), alone or in combination, on the incidences 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 aged 70 years and older, who had no major health events in the 5 years prior to enrolment, recruited from Switzerland, Germany, Austria, France, and Portugal between December 2012 and November 2014. Participants were randomly assigned to supplementation with 2000 international units/day of vitamin D3 and/or 1 g/day of marine omega-3s, and/or a SHEP compared with placebo and/or control exercise over 3 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, the main effects are reported based on a modified intent-to-treat analysis. RESULTS: Of 2157 randomized participants, 1900 (88%) completed the study. The mean age was 74.9 years, 61.7% were women, 40.7% had a 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 the SHEP had no benefit on total falls, whilst supplementation with omega-3s compared to no omega-3 supplementation reduced total falls by 10% (incidence rate ratio = 0.90; 95% CI, 0.81-1.00; P = 0.04). CONCLUSIONS: Among generally healthy, active, and vitamin D-replete older adults, omega-3 supplementation may have a modest benefit on the incidence of total falls, whilst a daily high dose of vitamin D or a SHEP had no benefit.