The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids, compared to placebo, reduce the incidence and/or progression of age-related macular degeneration (AMD).
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Primary Purpose: Prevention
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Study Primary Completion Date: December 2019
This ancillary study to the VITamin D and OmegA-3 TriaL (VITAL) will examine whether vitamin D3 and omega-3 fatty acids can help prevent the onset or progression of age-related macular degeneration (AMD). The study will also examine whether vitamin D3 and omega-3 fatty acids interact with each other, or with specific genes associated with AMD or vitamin D3 or omega-3 fatty acid metabolic activity, to affect the risk of developing AMD.
- Drug: Omega-3 fatty acids (fish oil)
- Dietary Supplement: Vitamin D3
- Dietary Supplement: Vitamin D3 placebo
- Dietary Supplement: Fish oil placebo
Arms, Groups and Cohorts
- Active Comparator: Vitamin D + fish oil placebo
- Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo
- Active Comparator: Vitamin D placebo + fish oil
- Vitamin D placebo Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg. of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
- Placebo Comparator: Vitamin D placebo + fish oil placebo
- Vitamin D placebo fish oil placebo
- Active Comparator: Vitamin D + fish oil
- Vitamin D (cholecalciferol), 2000 IU per day Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg. of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
Clinical Trial Outcome Measures
- Age-related macular degeneration
- Time Frame: 5 years
- Report of a diagnosis of age-related macular degeneration confirmed by medical record review.
Participating in This Clinical Trial
- All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Brigham and Women’s Hospital
- National Eye Institute (NEI)
- Provider of Information About this Clinical Study
- Principal Investigator: William G. Christen, Associate Professor – Brigham and Women’s Hospital
- Overall Official(s)
- Debra A Schaumberg, ScD, Principal Investigator, Brigham and Women’s Hospital
- William G Christen, ScD, Principal Investigator, Brigham and Women’s Hospital
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