Cataract and AMD in a Trial of a Multivitamin and Cocoa Extract

Overview

COSMOS-Eye is an ancillary study of the COcoa-Supplement and Multivitamins Outcomes Study (COSMOS; NCT02422745). COSMOS is a randomized clinical trial of cocoa extract supplement (containing a total of 600 mg/d flavanols, including 80 mg (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. This ancillary study is being conducted among participants in COSMOS and will examine whether the cocoa extract supplement or the multivitamin supplement reduces the risk of cataract and AMD, two leading causes of visual impairment in US men and women.

Full Title of Study: “Cataract and AMD in a Trial of a Multivitamin and Cocoa Extract (COSMOS-Eye)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2020

Detailed Description

COSMOS-Eye is an ancillary study of cataract and AMD utilizing resources and data from the COcoa-Supplement and Multivitamins Outcomes Study (COSMOS), a randomized, double-blind, placebo-controlled, 2×2 factorial trial of a high-quality cocoa extract supplement (Mars Symbioscience) and Centrum Silver multivitamin (Pfizer) in the prevention of cardiovascular disease and cancer among 12,000 women aged ≥65 years and 6,000 men aged ≥60 years.

Women will be recruited among active Women's Health Initiative (WHI) Extension Study participants, and men will be recruited among non-randomized respondents to the VITamin D and OmegA-3 Trial (VITAL). Women who responded but were not randomized into VITAL will also be included as well as other women and men who express interest in research being conducted at Brigham and Women's Hospital.

Participants will take three pills each day: two capsules that contain either cocoa extract or cocoa extract placebo, and one tablet that contains either multivitamin or multivitamin placebo. Participants will receive their study pills in convenient calendar packs via U.S. mail.

Participants also will be asked to complete short mailed questionnaires each year. The questionnaires ask about health; lifestyle habits, such as diet, physical activity, and smoking; use of medications and dietary supplements; family history of illness and new medical diagnoses including cataract and AMD.

Participants who report cataract or AMD will be asked to provide contact information for their eye doctor(s) as well as written consent to obtain the medical records. Eye doctors will be contacted by mail and asked to complete a cataract (or AMD) questionnaire or, alternatively, forward a complete copy of the patient's medical records pertaining to the diagnosis.

Interventions

  • Dietary Supplement: Cocoa extract
  • Dietary Supplement: Multivitamin
  • Dietary Supplement: Cocoa extract placebo
  • Dietary Supplement: Multivitamin placebo

Arms, Groups and Cohorts

  • Active Comparator: Cocoa extract + multivitamin
    • Dietary Supplement: Cocoa extract (2 capsules each day containing a total of 600 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine) Dietary Supplement: Multivitamin
  • Active Comparator: Cocoa extract + multivitamin placebo
    • Dietary Supplement: Cocoa extract (2 capsules each day containing a total of 600 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine) Dietary Supplement: Multivitamin placebo
  • Active Comparator: Cocoa extract placebo + multivitamin
    • Dietary Supplement: Multivitamin Dietary Supplement: Cocoa extract placebo
  • Placebo Comparator: Cocoa extract placebo + multivitamin placebo
    • Dietary Supplement: Cocoa extract placebo Dietary Supplement: Multivitamin placebo

Clinical Trial Outcome Measures

Primary Measures

  • Cataract
    • Time Frame: 5 years
    • Incident age-related cataract responsible for a reduction in best-corrected visual acuity to 20/30 or worse
  • Total AMD events
    • Time Frame: 5 years
    • Composite of incident AMD plus cases of progression to advanced AMD (neovascular AMD plus central geographic atrophy) among participants with prevalent AMD at baseline

Secondary Measures

  • Cataract surgery
    • Time Frame: 5 years
    • Incident extraction of an age-related lens opacity
  • Total cataract events
    • Time Frame: 5 years
    • Composite of incident cataract plus cataract surgery among participants with prevalent cataract at baseline
  • AMD
    • Time Frame: 5 years
    • Incident AMD with or without vision loss
  • Visually-significant AMD
    • Time Frame: 5 years
    • Incident AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse
  • Advanced AMD
    • Time Frame: 5 years
    • Incident advanced AMD (neovascular or geographic atrophy)

Participating in This Clinical Trial

Participants in COSMOS who 1) report a diagnosis of cataract or AMD, or extraction of cataract, and 2) provide written consent to obtain the medical records for the reported endpoint, are eligible for this ancillary study.

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: William G. Christen, Associate Professor – Brigham and Women’s Hospital

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