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

July 28, 2023 updated by: William G. Christen, Brigham and Women's Hospital
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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25871

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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])
Dietary supplement: Vitamin D3 placebo
Drug: Omega-3 fatty acids (fish oil)
Other Names:
  • Omacor
Placebo Comparator: Vitamin D placebo + fish oil placebo

Vitamin D placebo

fish oil placebo
Dietary supplement: Fish oil placebo
Dietary supplement: Vitamin D3 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])
Dietary supplement: Vitamin D3
Other Names:
  • cholecalciferol
Drug: Omega-3 fatty acids (fish oil)
Other Names:
  • Omacor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With an AMD Event
Time Frame: 5 years
AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline
5 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Incident AMD
Time Frame: 5 years
Incident AMD with or without vision loss to 20/30 or worse; a component of the composite end point of AMD Events
5 years
Number of Participants With AMD Progression
Time Frame: 5 years
Progression to advanced AMD among participants with AMD at baseline; a component of the composite end point of AMD Events
5 years
Number of Participants With an AMD Event, Excluding the First Two Years of Follow-up
Time Frame: 5 years (excluding the first two years of follow-up)
AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline
5 years (excluding the first two years of follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Eye Institute (NEI)

Investigators

  • Principal Investigator: Debra A Schaumberg, ScD, Brigham and Women's Hospital
  • Principal Investigator: William G Christen, ScD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2019

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimated)

February 1, 2013

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012P001797
  • R01EY021900 (U.S. NIH Grant/Contract)
  • 2012P000724 (Other Identifier: Brigham and Women's Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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