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Effect of Vitamin D Supplementation, Omega-3 Fatty Acid Supplementation, or a Strength-Training Exercise Program on Clinical Outcomes in Older Adults: The DO-HEALTH Randomized Clinical Trial.

Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland. Department of Geriatric Medicine and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland. University Clinic for Acute Geriatric Care, City Hospital Waid & Triemli, Zurich, Switzerland. Gérontopôle de Toulouse, Institut du Vieillissement, Center Hospitalo-Universitaire de Toulouse, Toulouse, France. UMR INSERM 1027, University of Toulouse III, Toulouse, France. Division of Bone Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland. University Department of Geriatric Medicine Felix Platter and University of Basel, Basel, Switzerland. Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal. Coimbra Institute for Clinical and Biomedical Research (iCBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal. Department for Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria. NIHR Manchester Biomedical Research Center, Manchester University NHS Foundation Trust, Manchester Academic Health Science Center, Manchester, England. Rheumatology, Boston University School of Medicine, Boston, Massachusetts. MRC Arthritis Research UK Center for Integrated Research Into Musculoskeletal Ageing, University of Sheffield, Sheffield, England. Academic Unit of Bone Metabolism, Department of Oncology and Metabolism, The Mellanby Center for Bone Research, University of Sheffield, Sheffield, England. Department of Physiology and Biochemistry of Nutrition, Max Rubner-Institut, Karlsruhe, Germany. Center for Healthy Aging, Department of Medicine III Dresden University Medical Center, Dresden, Germany. Center for Regenerative Therapies Dresden, Technische Universität Dresden, Dresden, Germany. Center for Muscle and Bone Research, Department of Radiology, Charité Universitätsmedizin Berlin, Berlin, Germany. Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts. Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, Massachusetts. Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts. Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Department of Public Health, Health Services Research, and Health Technology Assessment, UMIT-University for Health Sciences, Medical Informatics, and Technology, Hall in Tirol, Austria. Center for Health Decision Science, Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts. Program on Cardiovascular Research, Institute for Technology Assessment and Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston. Department of Geriatrics, University of Basel, Basel, Switzerland. Center for Metabolic Diseases, University of Sheffield Medical School, Sheffield, England. Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, Australia. Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.

JAMA. 2020;(18):1855-1868
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Abstract

IMPORTANCE The benefits of vitamin D, omega-3 fatty acids, and exercise in disease prevention remain unclear. OBJECTIVE To test whether vitamin D, omega-3s, and a strength-training exercise program, alone or in combination, improved 6 health outcomes among older adults. DESIGN, SETTING, AND PARTICIPANTS Double-blind, placebo-controlled, 2 × 2 × 2 factorial randomized clinical trial among 2157 adults aged 70 years or older who had no major health events in the 5 years prior to enrollment and had sufficient mobility and good cognitive status. Patients were recruited between December 2012 and November 2014, and final follow-up was in November 2017. INTERVENTIONS Participants were randomized to 3 years of intervention in 1 of the following 8 groups: 2000 IU/d of vitamin D3, 1 g/d of omega-3s, and a strength-training exercise program (n = 264); vitamin D3 and omega-3s (n = 265); vitamin D3 and exercise (n = 275); vitamin D3 alone (n = 272); omega-3s and exercise (n = 275); omega-3s alone (n = 269); exercise alone (n = 267); or placebo (n = 270). MAIN OUTCOMES AND MEASURES The 6 primary outcomes were change in systolic and diastolic blood pressure (BP), Short Physical Performance Battery (SPPB), Montreal Cognitive Assessment (MoCA), and incidence rates (IRs) of nonvertebral fractures and infections over 3 years. Based on multiple comparisons of 6 primary end points, 99% confidence intervals are presented and P < .01 was required for statistical significance. RESULTS Among 2157 randomized participants (mean age, 74.9 years; 61.7% women), 1900 (88%) completed the study. Median follow-up was 2.99 years. Overall, there were no statistically significant benefits of any intervention individually or in combination for the 6 end points at 3 years. For instance, the differences in mean change in systolic BP with vitamin D vs no vitamin D and with omega-3s vs no omega-3s were both -0.8 (99% CI, -2.1 to 0.5) mm Hg, with P < .13 and P < .11, respectively; the difference in mean change in diastolic BP with omega-3s vs no omega-3s was -0.5 (99% CI, -1.2 to 0.2) mm Hg; P = .06); and the difference in mean change in IR of infections with omega-3s vs no omega-3s was -0.13 (99% CI, -0.23 to -0.03), with an IR ratio of 0.89 (99% CI, 0.78-1.01; P = .02). No effects were found on the outcomes of SPPB, MoCA, and incidence of nonvertebral fractures). A total of 25 deaths were reported, with similar numbers in all treatment groups. CONCLUSIONS AND RELEVANCE Among adults without major comorbidities aged 70 years or older, treatment with vitamin D3, omega-3s, or a strength-training exercise program did not result in statistically significant differences in improvement in systolic or diastolic blood pressure, nonvertebral fractures, physical performance, infection rates, or cognitive function. These findings do not support the effectiveness of these 3 interventions for these clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01745263.

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