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

Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01782352
• Other study ID #: 2012P001797
• Secondary ID: R01EY0219002012P
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2010
• Est. completion date: September 2024

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25871
• Est. completion date: September 2024
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Omega-3 fatty acids (fish oil)

Dietary Supplement:
• Vitamin D3

• Vitamin D3 placebo

• Fish oil placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Incident AMD	Incident AMD with or without vision loss to 20/30 or worse; a component of the composite end point of AMD Events	5 years
Other	Number of Participants With AMD Progression	Progression to advanced AMD among participants with AMD at baseline; a component of the composite end point of AMD Events	5 years
Other	Number of Participants With an AMD Event, 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)
Primary	Number of Participants With an AMD Event	AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline	5 years
Secondary	Number of Participants With Incident Visually-Significant AMD	AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse	5 years
Secondary	Number of Participants With Incident Advanced AMD		5 years

External Links

•   VITAL study website