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