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

NCT03205202 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21442

Last updated 2021-09-17

No results posted yet for this study

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 500 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.

Conditions

  • Cataract
  • Age Related Macular Degeneration

Interventions

DIETARY_SUPPLEMENT

Cocoa extract

DIETARY_SUPPLEMENT

Multivitamin

DIETARY_SUPPLEMENT

Cocoa extract placebo

DIETARY_SUPPLEMENT

Multivitamin placebo

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2022-05-31
Completion
2022-10-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03205202 on ClinicalTrials.gov