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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
William G. Christen, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01782352
First received: January 31, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Age-related macular degeneration [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Report of a diagnosis of age-related macular degeneration confirmed by medical record review.


Estimated Enrollment: 20000
Study Start Date: July 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D + fish oil placebo

Vitamin D3 (cholecalciferol), 2000 IU per day

Fish oil placebo

 Dietary Supplement: Vitamin D3
Other Name: 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 Name: 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 Name: Omacor
Dietary Supplement: Vitamin D3
Other Name: cholecalciferol

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782352

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
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
  More Information

Additional Information:
VITAL study website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: William G. Christen, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01782352     History of Changes
Other Study ID Numbers: 2012P001797, R01EY021900, 2012P000724
Study First Received: January 31, 2013
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
age-related macular degeneration
incidence
progression

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013