Journal article
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.
- Bischoff-Ferrari HA Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland.
- Vellas B Gérontopôle de Toulouse, Institut du Vieillissement, Center Hospitalo-Universitaire de Toulouse, Toulouse, France.
- Rizzoli R Division of Bone Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
- Kressig RW University Department of Geriatric Medicine Felix Platter and University of Basel, Basel, Switzerland.
- da Silva JAP Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
- Blauth M Department for Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria.
- Felson DT NIHR Manchester Biomedical Research Center, Manchester University NHS Foundation Trust, Manchester Academic Health Science Center, Manchester, England.
- McCloskey EV MRC Arthritis Research UK Center for Integrated Research Into Musculoskeletal Ageing, University of Sheffield, Sheffield, England.
- Watzl B Department of Physiology and Biochemistry of Nutrition, Max Rubner-Institut, Karlsruhe, Germany.
- Hofbauer LC Center for Healthy Aging, Department of Medicine III Dresden University Medical Center, Dresden, Germany.
- Felsenberg D Center for Muscle and Bone Research, Department of Radiology, Charité Universitätsmedizin Berlin, Berlin, Germany.
- Willett WC Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
- Dawson-Hughes B Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.
- Manson JE Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
- Siebert U Department of Public Health, Health Services Research, and Health Technology Assessment, UMIT-University for Health Sciences, Medical Informatics, and Technology, Hall in Tirol, Austria.
- Theiler R Department of Geriatric Medicine and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.
- Staehelin HB Department of Geriatrics, University of Basel, Basel, Switzerland.
- de Godoi Rezende Costa Molino C Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland.
- Chocano-Bedoya PO Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland.
- Abderhalden LA Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland.
- Egli A Center on Aging and Mobility, University Hospital Zurich, City Hospital Waid & Triemli and University of Zurich, Zurich, Switzerland.
- Kanis JA Center for Metabolic Diseases, University of Sheffield Medical School, Sheffield, England.
- Orav EJ Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
- 2020-11-10
Published in:
- JAMA. - 2020
Aged
Aged, 80 and over
Cholecalciferol
Cognition Disorders
Dietary Supplements
Double-Blind Method
Fatty Acids, Omega-3
Female
Follow-Up Studies
Fractures, Bone
Health Status
Humans
Hypertension
Immunity
Male
Physical Fitness
Resistance Training
Treatment Outcome
Vitamins
English
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1001/jama.2020.16909
- PMID 33170239
- Persistent URL
- https://sonar.ch/global/documents/199086
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