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

NCT01782352 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25871

Last updated 2023-08-08

Study results available
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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).

Conditions

  • Age-related Macular Degeneration

Interventions

DRUG

Omega-3 fatty acids (fish oil)

DIETARY_SUPPLEMENT

Vitamin D3

DIETARY_SUPPLEMENT

Vitamin D3 placebo

DIETARY_SUPPLEMENT

Fish oil placebo

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Debra A Schaumberg, ScD · Brigham and Women's Hospital

  • William G Christen, ScD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2019-12-31
Completion
2024-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01782352 on ClinicalTrials.gov