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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
25,871
Brigham and Women's Hospital
Boston, Massachusetts, United States
Number of Participants With an AMD Event
AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline
Time frame: 5 years
Number of Participants With Incident Visually-Significant AMD
AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse
Time frame: 5 years
Number of Participants With Incident Advanced AMD
Time frame: 5 years
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