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Effects of vitamin D, omega-3 and a simple strength exercise programme in cardiovascular disease prevention: The DO-HEALTH randomized controlled trial.

Department of Geriatrics and Aging Research, University of Zurich, Zurich, Switzerland; Centre on Aging and Mobility, University of Zurich, Zurich, Switzerland. Centre on Aging and Mobility, University of Zurich, Zurich, Switzerland. Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Laboratory, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France; UMR INSERM 1027, University of Toulouse III, Toulouse, France; IHU HealthAge, University Hospital Toulouse, France. Interdisciplinary Lipid Metabolic Center, Charité Universitätsmedizin Berlin, 13353 Berlin, Germany. Institute of Clinical Chemistry, University of Zurich and University Hospital Zurich, Zurich, Switzerland. Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland. Division of Bone Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland. Centro Hospitalare Universitário de Coimbra, Coimbra, Portugal; Coimbra Institute for Clinical and Biomedical Research (ICBR), Faculty of Medicine, University of Coimbra, Coimbra, Portugal. University Department of Geriatric Medicine FELIX PLATTER and University of Basel, Basel, Switzerland. Centre for Metabolic Diseases, University of Sheffield Medical School, Sheffield, United Kingdom; Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, Australia. Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Department of Geriatrics and Aging Research, University of Zurich, Zurich, Switzerland; Centre on Aging and Mobility, University of Zurich, Zurich, Switzerland; Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France; UMR INSERM 1027, University of Toulouse III, Toulouse, France; IHU HealthAge, University Hospital Toulouse, France. Electronic address: heikea.bischoff-ferrari@uzh.ch.

The journal of nutrition, health & aging. 2024;(2):100037
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Abstract

BACKGROUND The effects of non-pharmaceutical interventions in the prevention of cardiovascular diseases (CVD) in older adults remains unclear. Therefore, the aim was to investigate the effect of 2000 IU/day of vitamin D3, omega-3 fatty acids (1 g/day), and a simple home strength exercise program (SHEP) (3×/week) on lipid and CVD biomarkers plasma changes over 3 years, incident hypertension and major cardiovascular events (MACE). METHODS The risk of MACE (coronary heart event or intervention, heart failure, stroke) was an exploratory endpoint of DO-HEALTH, incident hypertension and change in biomarkers were secondary endpoints. DO-HEALTH is a completed multicentre, randomised, placebo-controlled, 2 × 2 × 2 factorial design trial enrolling 2157 Europeans aged ≥70 years. RESULTS Participants' median age was 74 [72, 77] years, 61.7% were women, 82.5% were at least moderately physically active, and 40.7% had 25(OH)D < 20 ng/mL at baseline. Compared to their controls, omega-3 increased HDL-cholesterol (difference in change over 3 years: 0.08 mmol/L, 95% CI 0.05-0.10), decreased triglycerides (-0.08 mmol/L, (95%CI -0.12 to -0.03), but increased total- (0.15 mmol/L, 95%CI 0.09; 0.2), LDL- (0.11 mmol/L, 0.06; 0.16), and non-HDL-cholesterol (0.07 mmol/L, 95%CI 0.02; 0.12). However, neither omega-3 (adjustedHR 1.00, 95%CI 0.64-1.56), nor vitamin D3 (aHR 1.37, 95%CI 0.88-2.14), nor SHEP (aHR 1.18, 95%CI 0.76-1.84) reduced risk of MACE or incident hypertension compared to control. CONCLUSION Among generally healthy, active, and largely vitamin D replete, older adults, treatment with omega-3, vitamin D3, and/or SHEP had no benefit on MACE prevention. Only omega-3 supplementation changed lipid biomarkers, but with mixed effects. TRIAL REGISTRATION CLINICALTRIALS. GOV IDENTIFIER NCT01745263.

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