Clinical trial NCT01782352: Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)
Official title: Age-related Macular Degeneration (AMD) in the Vitamin D and Omega-3 Trial (VITAL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Age-related Macular Degeneration
Keywords: age-related macular degeneration
incidence
progression
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2013-02-01
Enrollment: 25871
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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).

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants With an AMD Event
timeFrame: 5 years
Secondary outcomes:
measure: Number of Participants With Incident Visually-Significant AMD
timeFrame: 5 years
measure: Number of Participants With Incident Advanced AMD
timeFrame: 5 years
Other outcomes:
measure: Number of Participants With Incident AMD
timeFrame: 5 years
measure: Number of Participants With AMD Progression
timeFrame: 5 years
measure: Number of Participants With an AMD Event, Excluding the First Two Years of Follow-up
timeFrame: 5 years (excluding the first two years of follow-up)
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Debra A Schaumberg, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: William G Christen, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christen WG, Cook NR, Manson JE, Buring JE, Chasman DI, Lee IM, Bubes V, Li C, Haubourg M, Schaumberg DA; VITAL Research Group. Effect of Vitamin D and omega-3 Fatty Acid Supplementation on Risk of Age-Related Macular Degeneration: An Ancillary Study of the VITAL Randomized Clinical Trial. JAMA Ophthalmol. 2020 Dec 1;138(12):1280-1289. doi: 10.1001/jamaophthalmol.2020.4409.