Journal
CONTEMPORARY CLINICAL TRIALS
Volume 68, Issue -, Pages 133-145Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2018.02.017
Keywords
Geriatric; Depression; Mood; Prevention; Cholecalciferol; Fish oil; Omega-3
Funding
- NIMH [R01 MH091448, P30 MH090333]
- National Cancer Institute of National Institutes of Health (NIH) [U01 CA138962, R01 CA138962]
- National Heart, Lung and Blood Institute (NHLBI) of National Institutes of Health (NIH)
- Office of Dietary Supplements of National Institutes of Health (NIH)
- National Institute of Neurological Disorders and Stroke of National Institutes of Health (NIH)
- National Center for Complementary and Alternative Medicine of National Institutes of Health (NIH)
- National Institute of Diabetes and Digestive and Kidney Diseases [DK088078, R01 DK088762]
- NHLBI [R01 HL101932, R01 HL102122]
- National Institute on Aging (NIA) [R01 AG036755]
- National Institute of Arthritis and Musculoskeletal and Skin Diseases [R01 AR059086, R01 AR060574]
- National Institute of Mental Health (NIMH) [R01 MH091448]
- University of Pittsburgh Medical Center Endowment in Geriatric Psychiatry
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Rationale: Depression is a leading cause of disease burden and disability for older adults; thus, prevention is a priority. Biologic and observational data support potential mental health benefits of vitamin D and omega-3 fatty acids; however, it is unclear whether these supplements can prevent late-life depression. Design: We describe the novel methodology of a large-scale study: VITAL-DEP (VITamin D and OmegA-3 TriaL-Depression Endpoint Prevention), an ancillary to the VITAL trial. Primary Aims of VITAL-DEP are to determine effects on prevention of depression and on trajectory of mood symptoms of long-term (mean = 5 years) supplementation with vitamin D (vitamin D3 [cholecalciferol], 2000 IU/day) and marine omega-3 fatty-acids (eicosapentaenoic acid + docosahexaenoic acid, 1 g/day), in a 2 x 2 factorial design, among 25,874 older adults. Secondary Aims will evaluate: vitamin D's effects among African-Americans (an at-risk group for vitamin D deficiency); both agents' effects among those with high-risk factors or sub-syndromal depression in a sub-set of similar to 1000 participants with detailed examinations at baseline and 2-year follow-up; whether baseline nutrient levels influence depression risk and/or modify agents' effects. Additional planned analyses will use pre-randomization blood samples available in similar to 17,000 participants to address whether key blomarkers and factors influence long-term mood and depression risk and/or the agents' effects. Conclusion: VITAL-DEP applies all modalities of state-of-the-art prevention research -universal, selective and indicated. VITAL-DEP will clarify effects of supplemental vitamin D and/or omega-3 on mood, and inform clinical care and public health guidelines on the use of these agents for prevention of depression in mid-life and older adults.
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