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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
William G. Christen, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01782352
First received: January 31, 2013
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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 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:


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.


Enrollment: 25875
Study Start Date: July 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:
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: May 29, 2014
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 August 20, 2014