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


N/A
50 Years
N/A
Open (Enrolling by invite only)
Both
Age-related Macular Degeneration

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Trial Information

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


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.


Inclusion Criteria:



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

Exclusion Criteria:

- None

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Age-related macular degeneration

Outcome Description:

Report of a diagnosis of age-related macular degeneration confirmed by medical record review.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Debra A Schaumberg, ScD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital

Authority:

United States: Institutional Review Board

Study ID:

2012P001797

NCT ID:

NCT01782352

Start Date:

July 2010

Completion Date:

June 2016

Related Keywords:

  • Age-Related Macular Degeneration
  • age-related macular degeneration
  • incidence
  • progression
  • Macular Degeneration

Name

Location
Brigham and Women's Hospital Boston, Massachusetts  02115