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

Not Applicable

Active, not recruiting

Interventions: Drug: Omega-3 fatty acids (fish oil)
Dietary Supplement: Vitamin D3 placebo
Dietary Supplement: Fish oil placebo
Dietary Supplement: Vitamin D3

Brief Summary: 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).

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Vitamin D placebo + fish oil	Omega-3 fatty acids (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 \[DHA\])
Vitamin D + fish oil	Omega-3 fatty acids (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 \[DHA\])
Vitamin D placebo + fish oil	Vitamin D3 placebo	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 \[DHA\])
Vitamin D placebo + fish oil placebo	Fish oil placebo	Vitamin D placebo fish oil placebo
Vitamin D + fish oil	Vitamin D3	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 \[DHA\])
Vitamin D + fish oil placebo	Vitamin D3	Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo
Vitamin D + fish oil placebo	Fish oil placebo	Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo
Vitamin D placebo + fish oil placebo	Vitamin D3 placebo	Vitamin D placebo fish oil placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants With an AMD Event	5 years	AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Incident Visually-Significant AMD	5 years	AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse
Number of Participants With Incident Advanced AMD	5 years