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Clinical trial

Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)

ID
Name
2012P001797
Description
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).
Trial arms
Trial start
2010-07-01
Estimated PCD
2019-12-01
Trial end
2024-09-01
Status
Active (not recruiting)
Treatment
Omega-3 fatty acids (fish oil)
Arms:
Vitamin D + fish oil, Vitamin D placebo + fish oil
Other names:
Omacor
Vitamin D3
Arms:
Vitamin D + fish oil, Vitamin D + fish oil placebo
Other names:
cholecalciferol
Vitamin D3 placebo
Arms:
Vitamin D placebo + fish oil, Vitamin D placebo + fish oil placebo
Fish oil placebo
Arms:
Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo
Size
25871
Primary endpoint
Number of Participants With an AMD Event
5 years
Eligibility criteria
Inclusion Criteria: * All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Exclusion Criteria: * None
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 25871, 'type': 'ACTUAL'}}
Updated at
2023-08-08

1 organization

1 product

1 indication

Organization
Brigham and Women's Hospital
Product
Omega-3 fatty acids
Indication
Macular Degeneration