VITAL-AMD: Prevention of AMD in the VITamin D and OmegA-3 Trial

Summary

Principal Investigator: Debra A Schaumberg
Abstract: DESCRIPTION (provided by applicant): This application proposes to study the efficacy of vitamin D3 and marine omega-3 fatty acid supplementation for prevention of age-related macular degeneration (AMD), the leading cause of blindness in the US. The study will leverage invaluable resources and data from the VITamin D and OmegA-3 TriaL (VITAL), a randomized, double-blind, placebo-controlled, 2x2 factorial trial designed to test vitamin D (vitamin D3 [cholecalciferol], 2000 IU/d) and marine omega-3 fatty acid (eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA], 1 g/d) supplements in the primary prevention of cancer and cardiovascular disease. The National Institutes of Health (1U01CA138962) is funding the main VITAL trial, which will study 20,000 men aged e60 y and women aged $ e65 y. Beginning in October 2010 and continuing throughout 2011, willing and eligible respondents to an $ invitational mailing will be enrolled in a 3-month run-in, and subsequently those who remain willing and eligible, and who report having taken at least two-thirds of study pills, will be randomly assigned to 1 of 4 treatment groups for 5 years: vitamin D3 (2000 IU/d) and fish oil (EPA+DHA, 1 g/d);vitamin D3 and fish oil placebo;vitamin D3 placebo and fish oil;and vitamin D3 placebo and fish oil placebo. At 1-year intervals, participants will receive a new supply of pills and a follow-up questionnaire on compliance, possible side effects, and incidence of endpoints. We propose to ascertain prevalent and incident AMD endpoints in the VITAL cohort in order to study the efficacy of vitamin D3 and fish oil in AMD prevention. The Primary Aims of this ancillary study are to test whether: 1) fish oil supplementation (EPA+DHA, 1g/d) reduces the incidence and progression of AMD and whether 2) vitamin D3 supplementation (2000 IU/d) reduces the incidence and progression of AMD. Secondary Aims will test for synergistic or antagonistic effects of vitamin D3 and fish oil, as well as interactions of vitamin D3 and fish oil with common AMD-associated genetic polymorphisms, and polymorphisms related to pathways involved in vitamin D3 or omega-3 fatty acid metabolic activity. This research is responsive to a program priority of the National Eye Institute's Strategic Plan to develop new treatments for AMD. We believe the timely start of the proposed AMD ancillary to the VITAL trial offers a unique but time-sensitive opportunity to obtain a reliable, efficient, and informative evaluation o the efficacy of two extremely promising preventive agents for AMD at a fraction of the cost of separate trials. Given our success with prior mail-based, large, simple trials and cohort studies, our experience with AMD, and our proposed methodology, we believe the trial will be able to provide either definitive positive or informative null results regarding the study hypotheses. PUBLIC HEALTH RELEVANCE: The purported health benefits of vitamin D and omega-3 fatty acids are receiving increasing attention in the medical literature and the popular press. However, definitive data on health benefits and risks of these agents are lacking. Findings from this large clinical trial will clarify the role of vitamin D and omega-3 fatty acid supplements in he prevention of AMD, the leading cause of blindness in US men and women.
Funding Period: 2012-09-01 - 2016-08-31
more information: NIH RePORT

Top Publications

  1. pmc Age-related macular degeneration and the incidence of cardiovascular disease: a systematic review and meta-analysis
    Juan Wu
    Department of Nutrition, Harvard School of Public Health, Boston, Massachusetts, United States of America
    PLoS ONE 9:e89600. 2014

Detail Information

Publications1

  1. pmc Age-related macular degeneration and the incidence of cardiovascular disease: a systematic review and meta-analysis
    Juan Wu
    Department of Nutrition, Harvard School of Public Health, Boston, Massachusetts, United States of America
    PLoS ONE 9:e89600. 2014
    ..However, results from prior epidemiologic studies have been inconsistent as to whether AMD is predictive of future CVD risk...

Research Grants62

  1. Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Joint Pain
    Karen H Costenbader; Fiscal Year: 2013
    ....
  2. A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
    Jae H Kang; Fiscal Year: 2013
    ..We propose an exciting substudy, incorporating cognitive testing among VITAL participants aged 65+ years to evaluate whether marine omega-3 fatty and vitamin D may be important in the maintenance of cognitive function in men and women. ..
  3. The Dry Eye Evaluation And Management (DREAM) Study: Coordinating Center
    Maureen G Maguire; Fiscal Year: 2013
    ..abstract_text> ..
  4. Community Networks Program: The Johns Hopkins Center to Reduce Cancer Disparities
    Adrian S Dobs; Fiscal Year: 2013
    ....
  5. Cardiovascular Inflammation Reduction Trial (CIRT)
    Paul M Ridker; Fiscal Year: 2013
    ..End of Abstract) ..
  6. Impact of vitamin D supplementation on cardiac structure and function
    Thomas J Wang; Fiscal Year: 2013
    ..The study represents a unique and cost- effective opportunity to investigate measures of cardiac structure and function in a large, diverse primary prevention trial. ..
  7. Cumulative Stress and CVD Risk in Middle-Aged and Older Women
    Michelle A Albert; Fiscal Year: 2013
    ..Thus, this proposed study will provide valuable clinical information that can result in the development of behavioral and therapeutic interventions aimed at decreasing the effects of cumulative stressors on CVD health. ..
  8. Testing Fish Oil Derivatives in Healing of Chronic Venous Leg Ulcers
    JODI CHRISTINE MCDANIEL; Fiscal Year: 2013
    ..If the three corollaries of our organizing hypothesis are supported, a full scale clinical trial evaluating the effects of EPA+DHA supplementation on cellular and molecular mechanisms of wound healing in CVLU patients will be proposed. ..
  9. Hopkins Center for Eliminate Cardiovascular Health Disparities
    Lisa A Cooper; Fiscal Year: 2013
    ..abstract_text> ..
  10. Women's Health Study: Continued Follow-up
    I Min Lee; Fiscal Year: 2013
    ..1 ..
  11. BIOLOGY OF NEUROENDOCRINE PEPTIDES
    Marc R Montminy; Fiscal Year: 2013
    ..Specifying the contributions of the CRF family of ligands and receptors to the maintenance of homeostasis and to stress-linked allostasis may improve our ability to manage diseases, including mood and metabolic disorders ..
  12. Omega-3 Fatty Acid Effects on Pancreatitis and Adenocarcinoma Development
    Christopher A Jolly; Fiscal Year: 2013
    ..This data may show an important role for the omega-3 PUFAs, especially EPA, in cancer prevention because they are well known anti-inflammatory agents and are widely consumed by people in the United States. ..
  13. Vitamin D and type 2 diabetes (D2d)
    Anastassios G Pittas; Fiscal Year: 2013
    ....
  14. EARLY EVENTS IN ALZHEIMER PATHOGENESIS
    SUE TILTON GRIFFIN; Fiscal Year: 2013
    ..The synergy between our aims, approaches, and measures will enable us to meet our goal of defining early cellular interactions toward development of rational interventions in AD. ..
  15. ASPirin in Reducing Events in the Elderly
    JOHN JAMES MCNEIL; Fiscal Year: 2013
    ..g., HRT, COX-2 inhibitors and anti-oxidant vitamins, has emphasized the need to formally establish safety and efficacy before such therapies enter routine practice. ..
  16. 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. ..
  17. VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture
    MERYL SUSAN LEBOFF; Fiscal Year: 2013
    ..Findings from this proposal will fill gaps in knowledge and inform clinical and public health recommendations. ..
  18. Zimmerman Program for the Molecular and Clinical Biology of VWD
    Robert R Montgomery; Fiscal Year: 2013
    ..Taken together this PPG will set the stage for the appropriate diagnosis and phenotypic understanding of VWD - both in the US and throughout the world. ..
  19. Comparative Mechanisms of Cancer Chemoprevention
    Roderick H Dashwood; Fiscal Year: 2013
    ..This application is innovative and timely in bridging basic mechanisms, preclinical models, and human studies of epigenetics and diet. ..
  20. Preclinical Pharmacogenomics and Synaptic Biomarkers for Alzheimer's Disease
    Gregory M Cole; Fiscal Year: 2013
    ....
  21. Prevalence and Impact of Frailty among Dialysis Patients
    Kirsten L Johansen; Fiscal Year: 2013
    ..abstract_text> ..
  22. Factors Modifying the Toxicity of Methylmercury in a Fish-Eating Population
    Philip W Davidson; Fiscal Year: 2013
    ..Rand's laboratory while genes and genetic variations in those genes linked to MeHg tolerance in Drosophila by Dr. Rand can help focus Dr. Broberg's work on SNPs that appear particularly important to the neurotoxicity of MeHg. ..
  23. Cardiovascular Inflammation Reduction Trial (CIRT): DCC
    Robert J Glynn; Fiscal Year: 2013
    ..End of Abstract) ..
  24. Management of Cancer-Treatment-Induced Bone Loss
    LUKE JOSEPH PEPPONE; Fiscal Year: 2013
    ..Dr. Peppone will use the training and data obtained by this award to develop into an independent clinical researcher in the cancer control field. ..
  25. A Pilot Study of the DASH Diet in Not-Well-Controlled Adult Asthma
    Jun Ma; Fiscal Year: 2013
    ..It meets NHLBI's funding priority for research to increase the evidence base for refining clinical guidelines and public health recommendations regarding dietary and other lifestyle modifications in asthma. ..
  26. Endogenous Anti-Inflammatory Lipid Mediators, Fish Oil and Post-Operative Atrial
    Dariush Mozaffarian; Fiscal Year: 2013
    ..placebo, on these MEFAs response;and the relationship of MEFAs levels with POAF. ..
  27. Obesity and Asthma: Genetics and Nutrigenetic Response to Omega-3 Fatty Acids
    Jason E Lang; Fiscal Year: 2013
    ..This project, through our ALA-ACRC affiliation, may be well positioned to transition into a large multicenter asthma trial. ..
  28. Comprehensive NeuroAIDS Core Center
    Kamel Khalili; Fiscal Year: 2013
    ..abstract_text> ..
  29. Structural bases of the functions of RNA-protein machines
    THOMAS ARTHUR STEITZ; Fiscal Year: 2013
    ..Also of interest will be the ways in which the structures and properties of RNA molecules can be utilized to carry out various biological functions often analogous to those performed by proteins. ..
  30. Colorectal Chemoprevention with Calcium and Vitamin D
    JOHN ANTHONY BARON; Fiscal Year: 2013
    ....