The VITamin D and OmegA-3 TriaL-Depression Endpoint Prevention (VITAL-DEP): Rationale and design of a large-scale ancillary study evaluating vitamin D and marine omega-3 fatty acid supplements for prevention of late-life depression

Contemp Clin Trials. 2018 May;68:133-145. doi: 10.1016/j.cct.2018.02.017. Epub 2018 Mar 8.

Abstract

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=5years) supplementation with vitamin D (vitamin D3 [cholecalciferol], 2000IU/day) and marine omega-3 fatty-acids (eicosapentaenoic acid + docosahexaenoic acid, 1g/day), in a 2×2 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 ~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 ~17,000 participants to address whether key biomarkers 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.

Trial registration: ClinicalTrials.gov NCT01169259 NCT01696435.

Keywords: Cholecalciferol; Depression; Fish oil; Geriatric; Mood; Omega-3; Prevention.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • African Americans
  • Aged
  • Depression* / blood
  • Depression* / diagnosis
  • Depression* / ethnology
  • Depression* / prevention & control
  • Dietary Supplements
  • Double-Blind Method
  • Fatty Acids, Omega-3 / administration & dosage*
  • Female
  • Humans
  • Male
  • Mental Health
  • Risk Factors
  • Treatment Outcome
  • Vitamin D Deficiency* / blood
  • Vitamin D Deficiency* / drug therapy
  • Vitamin D Deficiency* / ethnology
  • Vitamin D* / administration & dosage
  • Vitamin D* / blood
  • Vitamins / administration & dosage

Substances

  • Fatty Acids, Omega-3
  • Vitamins
  • Vitamin D

Associated data

  • ClinicalTrials.gov/NCT01169259
  • ClinicalTrials.gov/NCT01696435