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

Primary Purpose

Age-related Macular Degeneration

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Omega-3 fatty acids (fish oil)

Vitamin D3

Vitamin D3 placebo

Fish oil placebo

About this trial

This is an interventional prevention trial for Age-related Macular Degeneration focused on measuring age-related macular degeneration, incidence, progression

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

None

Sites / Locations

Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Vitamin D + fish oil placebo

Vitamin D placebo + fish oil

Vitamin D placebo + fish oil placebo

Vitamin D + fish oil

Arm Description

Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo

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])

Vitamin D placebo fish oil placebo

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])

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Incident Visually-Significant AMD

AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse

Number of Participants With Incident Advanced AMD

Full Information

NCT ID

NCT01782352

First Posted

January 31, 2013

Last Updated

July 28, 2023

Sponsor

Brigham and Women's Hospital

Collaborators

National Eye Institute (NEI)

1. Study Identification

Unique Protocol Identification Number

NCT01782352

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 2010 (undefined)

Primary Completion Date

December 2019 (Actual)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration

Keywords

age-related macular degeneration, incidence, progression

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25871 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D + fish oil placebo

Arm Type

Active Comparator

Arm Description

Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo

Arm Title

Vitamin D placebo + fish oil

Arm Type

Active Comparator

Arm Description

Arm Title

Vitamin D placebo + fish oil placebo

Arm Type

Placebo Comparator

Arm Description

Vitamin D placebo fish oil placebo

Arm Title

Vitamin D + fish oil

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Omega-3 fatty acids (fish oil)

Other Intervention Name(s)

Omacor

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

cholecalciferol

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3 placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

Fish oil placebo

Primary Outcome Measure Information:

Title

Number of Participants With an AMD Event

Description

AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Number of Participants With Incident Visually-Significant AMD

Description

AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse

Time Frame

5 years

Title

Number of Participants With Incident Advanced AMD

Time Frame

5 years

Other Pre-specified Outcome Measures:

Title

Number of Participants With Incident AMD

Description

Incident AMD with or without vision loss to 20/30 or worse; a component of the composite end point of AMD Events

Time Frame

5 years

Title

Number of Participants With AMD Progression

Description

Progression to advanced AMD among participants with AMD at baseline; a component of the composite end point of AMD Events

Time Frame

5 years

Title

Number of Participants With an AMD Event, Excluding the First Two Years of Follow-up

Description

AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline

Time Frame

5 years (excluding the first two years of follow-up)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Exclusion Criteria: None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Debra A Schaumberg, ScD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

William G Christen, ScD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33119047

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.

Results Reference

derived

Links:

URL

http://vitalstudy.org

Description

VITAL study website

Learn more about this trial

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

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