Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03205202
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2017
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
William G. Christen, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE June 29, 2017
First Posted Date  ICMJE July 2, 2017
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE June 1, 2015
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cataract and AMD in a Trial of a Multivitamin and Cocoa Extract
Official Title  ICMJE Cataract and AMD in a Trial of a Multivitamin and Cocoa Extract (COSMOS-Eye)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Cataract
  • Age Related Macular Degeneration
Intervention  ICMJE
  • Dietary Supplement: Cocoa extract
  • Dietary Supplement: Multivitamin
  • Dietary Supplement: Cocoa extract placebo
  • Dietary Supplement: Multivitamin placebo
Study Arms  ICMJE
  • 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

    Interventions:
    • 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

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

    Dietary Supplement: Multivitamin

    Dietary Supplement: Cocoa extract placebo

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

    Dietary Supplement: Cocoa extract placebo

    Dietary Supplement: Multivitamin placebo

    Interventions:
    • Dietary Supplement: Cocoa extract placebo
    • Dietary Supplement: Multivitamin placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Actual Enrollment  ICMJE
 (submitted: June 9, 2018)
21445
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2017)
18000
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03205202
Other Study ID Numbers  ICMJE 2016P001612
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party William G. Christen, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brigham and Women's Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP