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

Mass General Brigham

Status: Active, not recruiting

Conditions: Age-related Macular Degeneration

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01782352

R01EY021900 (U.S. NIH Grant/Contract)

2012P001797

2012P000724 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25,871 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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25,871 participants in 4 patient groups, including a placebo group

Vitamin D + fish oil placebo

Active Comparator group

Description:

Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Fish oil placebo

Vitamin D placebo + fish oil

Active Comparator group

Description:

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 \[DHA\])

Treatment:

Dietary Supplement: Vitamin D3 placebo

Drug: Omega-3 fatty acids (fish oil)

Vitamin D placebo + fish oil placebo

Placebo Comparator group

Description:

Vitamin D placebo fish oil placebo

Treatment:

Dietary Supplement: Fish oil placebo

Dietary Supplement: Vitamin D3 placebo

Vitamin D + fish oil

Active Comparator group

Description:

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 \[DHA\])

Treatment:

Dietary Supplement: Vitamin D3

Drug: Omega-3 fatty acids (fish oil)