VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL

Summary

Principal Investigator: OLIVIA IFEOMA OKEREKE
Abstract: DESCRIPTION (provided by applicant): We propose to evaluate the effects of vitamin D3 (1600 IU/day) and omega-3 fatty acid (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA], 1g/day) supplements on risk of late-life depression and depressive symptoms in the setting of an NIH-funded large-scale randomized trial, the VITamin D and OmegA-3 TriaL (VITAL, 1 U01 CA 138962). VITAL is a 2x2 factorial RCT designed to evaluate the efficacy of vitamin D3 and marine omega-3 fatty acid supplements in the primary prevention of cardiovascular disease and cancer among 20,000 older U.S. men and women. We will address two primary aims. First, we will test whether vitamin D or omega-3 supplementation reduces incident and recurrent depression rates among all participants in the trial. Cases of depression will be identified using questionnaires and additional data on psychiatric visits, diagnoses, and medications from the Centers for Medicare and Medicaid Services database. Second, we will test whether vitamin D or omega-3 supplementation yields better continuous mood scores on repeated measures over the 5-year study period. In addition, we will address three secondary aims. First, in a substudy of 1,000 high-risk participants, defined as persons with known risk factors for late-life depression (selective prevention) or with subsyndromal depressive symptoms (indicated prevention), we will test whether the agents are effective at reducing risk of depression and at yielding lower depression scores over time. Participants in this substudy will be recruited at four Clinical and Translational Science Center (CTSC) sites across the U.S. (Boston, Chicago, San Francisco, and Houston), and will undergo a psychiatric interview at baseline and at 2 years of follow-up (visits will be matched for season, to avoid seasonal bias for vitamin D). Second, we will address whether African-American race modifies effects of vitamin D supplementation on depression risk and on mood scores in the entire VITAL cohort (African-Americans are disproportionately affected by vitamin D insufficiency). Third, in a nested case-control design, we will assess whether baseline plasma levels of vitamin D and omega-3 fatty acids are related to depression risk, and whether they modify treatment effects. We will also be able to explore additive and/or synergistic effects of the agents, as well as effect modification by age, gender, baseline nutrient levels, baseline medical comorbidity, latitude, and physical activity. In summary, this proposal presents a highly efficient and innovative strategy to evaluate simultaneously the efficacy of vitamin D and omega-3 fatty acid supplementation for universal, selective and indicated prevention of late-life depression, as well as to provide characterization of relevant physiologic parameters that may influence this benefit. We request funds for depression case ascertainment, psychiatric assessments, and assays of pre-randomization blood levels of vitamin D and fatty acids in a nested case-control sample. In order to test our hypotheses and to complete pre- randomization psychiatric assessments, it is critically important and time-sensitive that this ancillary study be undertaken in parallel to the enrollment period for the parent VITAL trial, which is scheduled to begin in 2010.
Funding Period: 2010-09-29 - 2015-06-30
more information: NIH RePORT

Top Publications

  1. pmc Bidirectional association between depression and obesity in middle-aged and older women
    A Pan
    Department of Nutrition, Harvard School of Public Health, Boston, MA 02115, USA
    Int J Obes (Lond) 36:595-602. 2012
  2. pmc Depression and risk of stroke morbidity and mortality: a meta-analysis and systematic review
    An Pan
    Department of Nutrition, Harvard School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA
    JAMA 306:1241-9. 2011
  3. pmc The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease
    JoAnn E Manson
    Division of Preventive Medicine, Department of Medicine, Brigham and Women s Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, MA 02215, United States
    Contemp Clin Trials 33:159-71. 2012
  4. pmc Early intervention to reduce the global health and economic burden of major depression in older adults
    Charles F Reynolds
    School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania 15213, USA
    Annu Rev Public Health 33:123-35. 2012
  5. pmc Bidirectional association between depression and metabolic syndrome: a systematic review and meta-analysis of epidemiological studies
    An Pan
    Department of Nutrition, Harvard School of Public Health, Boston, Massachusetts, USA
    Diabetes Care 35:1171-80. 2012

Detail Information

Publications5

  1. pmc Bidirectional association between depression and obesity in middle-aged and older women
    A Pan
    Department of Nutrition, Harvard School of Public Health, Boston, MA 02115, USA
    Int J Obes (Lond) 36:595-602. 2012
    ..We aimed to examine the bidirectional relationship in middle-aged and elderly women...
  2. pmc Depression and risk of stroke morbidity and mortality: a meta-analysis and systematic review
    An Pan
    Department of Nutrition, Harvard School of Public Health, 655 Huntington Ave, Boston, MA 02115, USA
    JAMA 306:1241-9. 2011
    ..Several studies have suggested that depression is associated with an increased risk of stroke; however, the results are inconsistent...
  3. pmc The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease
    JoAnn E Manson
    Division of Preventive Medicine, Department of Medicine, Brigham and Women s Hospital, Harvard Medical School, 900 Commonwealth Avenue East, Boston, MA 02215, United States
    Contemp Clin Trials 33:159-71. 2012
    ....
  4. pmc Early intervention to reduce the global health and economic burden of major depression in older adults
    Charles F Reynolds
    School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania 15213, USA
    Annu Rev Public Health 33:123-35. 2012
    ..We suggest in this review that the time is right for research into the translation of depression-prevention strategies for use in LMICs...
  5. pmc Bidirectional association between depression and metabolic syndrome: a systematic review and meta-analysis of epidemiological studies
    An Pan
    Department of Nutrition, Harvard School of Public Health, Boston, Massachusetts, USA
    Diabetes Care 35:1171-80. 2012
    ..However, the results have been inconsistent. This meta-analysis aimed to summarize the current evidence from cross-sectional and prospective cohort studies that evaluated this association...

Research Grants30

  1. Effects of Vitamin D and Marine Omega-3 Fatty Acids on Anemia in the Elderly
    Nancy Berliner; Fiscal Year: 2013
    ..abstract_text> ..
  2. Hopkins Center for Eliminate Cardiovascular Health Disparities
    Lisa A Cooper; Fiscal Year: 2013
    ..abstract_text> ..
  3. Effect of Vitamin D and Omega-3 Fatty Acids on Blood Pressure and Hypertension
    Howard D Sesso; Fiscal Year: 2013
    ..Because high blood pressure is responsible for one out of every six deaths in the United States, the results of this study could possibly improve the health of many people. ..
  4. The VITAL Rhythm Study
    Christine M Albert; Fiscal Year: 2013
    ..If either agent significantly lowers AF risk, then these agents would represent one of the first therapies proven effective for the primary prevention of this growing morbid disease. ..
  5. Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Joint Pain
    Karen H Costenbader; Fiscal Year: 2013
    ....
  6. Early Phase Psychosis: Informing Treatment Decisions
    John M Kane; Fiscal Year: 2013
    ..Our ability to intervene appropriately, effectively and consistently in this population can have profound long-term public health consequences. ..
  7. Effects of vitamin D and omega-3 fatty acids on infectious diseases and hCAP18
    Carlos A Camargo; Fiscal Year: 2013
    ..The findings may have direct clinical and public health impact for the prevention of infections in older adults. ..
  8. Lung VITamin D and OmegA-3 TriaL (Lung VITAL)
    Diane R Gold; Fiscal Year: 2013
    ..If vitamin D or marine omega-3 fatty acid supplementation reduce COPD and asthma exacerbations, reduce decline of lung function, improve asthma control and/or reduce pneumonia risk, this would be of great benefit to public health. ..
  9. Comprehensive NeuroAIDS Core Center
    Kamel Khalili; Fiscal Year: 2013
    ..abstract_text> ..