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Cataract and AMD in a Trial of a Multivitamin and Cocoa Extract (COSMOS-Eye)

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ClinicalTrials.gov Identifier: NCT03205202
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2017
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
William G. Christen, Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cataract Age Related Macular Degeneration Dietary Supplement: Cocoa extract Dietary Supplement: Multivitamin Dietary Supplement: Cocoa extract placebo Dietary Supplement: Multivitamin placebo Phase 4

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, 2x2 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21445 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Cataract and AMD in a Trial of a Multivitamin and Cocoa Extract (COSMOS-Eye)
Actual Study Start Date : June 1, 2015
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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

Dietary Supplement: Cocoa extract
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

Dietary Supplement: Cocoa extract
Dietary Supplement: Multivitamin placebo
Active Comparator: Cocoa extract placebo + multivitamin

Dietary Supplement: Multivitamin

Dietary Supplement: Cocoa extract placebo

Dietary Supplement: Multivitamin
Dietary Supplement: Cocoa extract placebo
Placebo Comparator: Cocoa extract placebo + multivitamin placebo

Dietary Supplement: Cocoa extract placebo

Dietary Supplement: Multivitamin placebo

Dietary Supplement: Cocoa extract placebo
Dietary Supplement: Multivitamin placebo



Primary Outcome Measures :
  1. Cataract [ Time Frame: 5 years ]
    Incident age-related cataract responsible for a reduction in best-corrected visual acuity to 20/30 or worse

  2. 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 Outcome Measures :
  1. Cataract surgery [ Time Frame: 5 years ]
    Incident extraction of an age-related lens opacity

  2. Total cataract events [ Time Frame: 5 years ]
    Composite of incident cataract plus cataract surgery among participants with prevalent cataract at baseline

  3. AMD [ Time Frame: 5 years ]
    Incident AMD with or without vision loss

  4. Visually-significant AMD [ Time Frame: 5 years ]
    Incident AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse

  5. Advanced AMD [ Time Frame: 5 years ]
    Incident advanced AMD (neovascular or geographic atrophy)



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
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.
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Responsible Party: William G. Christen, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03205202    
Other Study ID Numbers: 2016P001612
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Cataract
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lens Diseases