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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01782352

Collaborator

National Eye Institute (NEI) (NIH)

25,871

Enrollment

Location

Arms

146

Duration (Months)

177.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Age-related Macular Degeneration	Drug: Omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin D3 placebo Dietary Supplement: Fish oil placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

25871 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vitamin D + fish oil placebo Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo	Dietary Supplement: Vitamin D3 Other Names: cholecalciferol Dietary Supplement: Fish oil placebo
Active Comparator: 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])	Drug: Omega-3 fatty acids (fish oil) Other Names: Omacor Dietary Supplement: Vitamin D3 placebo
Placebo Comparator: Vitamin D placebo + fish oil placebo Vitamin D placebo fish oil placebo	Dietary Supplement: Vitamin D3 placebo Dietary Supplement: Fish oil placebo
Active Comparator: 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])	Drug: Omega-3 fatty acids (fish oil) Other Names: Omacor Dietary Supplement: Vitamin D3 Other Names: cholecalciferol