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

NCT01782352 | Unknown Results DMC

• 3 other identifiers: 2012P001797R01EY0219002012P000724
• Study Type: interventional
• Target: 25,871
• Locations: 1 country
• Sites: 1

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).

Conditions

Age-related Macular Degeneration

Keywords

age-related macular degeneration; incidence; progression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Incident Visually-Significant AMD

  5 years

• Number of Participants With Incident Advanced AMD

  5 years

Other Outcomes (3)

• Number of Participants With Incident AMD

  5 years

• Number of Participants With AMD Progression

  5 years

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

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

Study Arms (4)

Vitamin D + fish oil placebo

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D3; Dietary Supplement: Fish oil placebo

Vitamin D placebo + fish oil

ACTIVE COMPARATOR

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); Dietary Supplement: Vitamin D3 placebo

Vitamin D placebo + fish oil placebo

PLACEBO COMPARATOR

Vitamin D placebo fish oil placebo

Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Fish oil placebo

Vitamin D + fish oil

ACTIVE COMPARATOR

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); Dietary Supplement: Vitamin D3

Interventions

Omega-3 fatty acids (fish oil) DRUG

Also known as: Omacor

Vitamin D + fish oil; Vitamin D placebo + fish oil

Vitamin D3 DIETARY_SUPPLEMENT

Also known as: cholecalciferol

Vitamin D + fish oil; Vitamin D + fish oil placebo

Vitamin D3 placebo DIETARY_SUPPLEMENT

Vitamin D placebo + fish oil; Vitamin D placebo + fish oil placebo

Fish oil placebo DIETARY_SUPPLEMENT

Vitamin D + fish oil placebo; Vitamin D placebo + fish oil placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 33119047 DERIVED

Related Links

• VITAL study website

MeSH Terms

Conditions

Macular Degeneration; Disease Progression

Interventions

Fatty Acids, Omega-3; Fish Oils; Omacor; Cholecalciferol

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids

Results Point of Contact

• Title: VITAL Study Director
• Organization: Brigham and Women's Hospital; 900 Commonwealth Ave, 3rd fl.; Boston, MA 02215

vitalstudy@partners.org

1-800-388-3963

Study Officials

• Debra A Schaumberg, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• William G Christen, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 1, 2013
• Study Start: July 1, 2010
• Primary Completion: December 1, 2019
• Study Completion: September 1, 2024
• Last Updated: August 8, 2023
• Results First Posted: August 22, 2022

Record last verified: 2023-07

Locations

US (1)