Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)
This trial is active, not recruiting.
|Condition||age-related macular degeneration|
|Treatments||omega-3 fatty acids (fish oil), vitamin d3, vitamin d3 placebo, fish oil placebo|
|Sponsor||Brigham and Women's Hospital|
|Collaborator||National Eye Institute (NEI)|
|Start date||July 2010|
|End date||October 2017|
|Trial size||25875 participants|
|Trial identifier||NCT01782352, 2012P000724, 2012P001797, R01EY021900|
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).
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
Age-related macular degeneration
time frame: 5 years
Male or female participants at least 50 years old.
Inclusion Criteria: - All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Exclusion Criteria:
|Official title||Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)|
|Principal investigator||Debra A Schaumberg, ScD|
|Description||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.|
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