Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)
NCT ID: NCT01782352
Last Updated: 2023-08-08
Study Results
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View full resultsBasic Information
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UNKNOWN
NA
25871 participants
INTERVENTIONAL
2010-07-31
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
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Vitamin D + fish oil placebo
Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo
Vitamin D3
Fish oil placebo
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 \[DHA\])
Omega-3 fatty acids (fish oil)
Vitamin D3 placebo
Vitamin D placebo + fish oil placebo
Vitamin D placebo
fish oil placebo
Vitamin D3 placebo
Fish oil placebo
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 \[DHA\])
Omega-3 fatty acids (fish oil)
Vitamin D3
Interventions
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Omega-3 fatty acids (fish oil)
Vitamin D3
Vitamin D3 placebo
Fish oil placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
ALL
Yes
Sponsors
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National Eye Institute (NEI)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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William G. Christen
Associate Professor
Principal Investigators
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Debra A Schaumberg, ScD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
William G Christen, ScD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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Christen WG, Cook NR, Manson JE, Buring JE, Chasman DI, Lee IM, Bubes V, Li C, Haubourg M, Schaumberg DA; VITAL Research Group. Effect of Vitamin D and omega-3 Fatty Acid Supplementation on Risk of Age-Related Macular Degeneration: An Ancillary Study of the VITAL Randomized Clinical Trial. JAMA Ophthalmol. 2020 Dec 1;138(12):1280-1289. doi: 10.1001/jamaophthalmol.2020.4409.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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VITAL study website
Other Identifiers
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2012P000724
Identifier Type: OTHER
Identifier Source: secondary_id
2012P001797
Identifier Type: -
Identifier Source: org_study_id
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