NCT03205202

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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21,442

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

6.9 years

First QC Date

June 29, 2017

Last Update Submit

September 13, 2021

Conditions

CataractAge Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

  • Cataract

    Incident age-related cataract responsible for a reduction in best-corrected visual acuity to 20/30 or worse

    5 years

  • Total AMD events

    Composite of incident AMD plus cases of progression to advanced AMD (neovascular AMD plus central geographic atrophy) among participants with prevalent AMD at baseline

    5 years

Secondary Outcomes (5)

  • Cataract surgery

    5 years

  • Total cataract events

    5 years

  • AMD

    5 years

  • Visually-significant AMD

    5 years

  • Advanced AMD

    5 years

Study Arms (4)

Cocoa extract + multivitamin

ACTIVE COMPARATOR

Dietary Supplement: Cocoa extract (2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine) Dietary Supplement: Multivitamin

Dietary Supplement: Cocoa extractDietary Supplement: Multivitamin

Cocoa extract + multivitamin placebo

ACTIVE COMPARATOR

Dietary Supplement: Cocoa extract (2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine) Dietary Supplement: Multivitamin placebo

Dietary Supplement: Cocoa extractDietary Supplement: Multivitamin placebo

Cocoa extract placebo + multivitamin

ACTIVE COMPARATOR

Dietary Supplement: Multivitamin Dietary Supplement: Cocoa extract placebo

Dietary Supplement: MultivitaminDietary Supplement: Cocoa extract placebo

Cocoa extract placebo + multivitamin placebo

PLACEBO COMPARATOR

Dietary Supplement: Cocoa extract placebo Dietary Supplement: Multivitamin placebo

Dietary Supplement: Cocoa extract placeboDietary Supplement: Multivitamin placebo

Interventions

Cocoa extractDIETARY_SUPPLEMENT
Cocoa extract + multivitaminCocoa extract + multivitamin placebo
MultivitaminDIETARY_SUPPLEMENT
Cocoa extract + multivitaminCocoa extract placebo + multivitamin
Cocoa extract placeboDIETARY_SUPPLEMENT
Cocoa extract placebo + multivitaminCocoa extract placebo + multivitamin placebo
Multivitamin placeboDIETARY_SUPPLEMENT
Cocoa extract + multivitamin placeboCocoa extract placebo + multivitamin placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Christen WG, Rist PM, Moorthy MV, Smith DC, Holman B, Clar A, Glynn RJ, Mares JA, Sobrin L, Shadyab AH, Allison MA, Millen AE, Manson JE, Sesso HD; COSMOS Research Group. Cocoa Flavanol Supplementation and Risk of Age-Related Macular Degeneration: An Ancillary Study of the COSMOS Randomized Clinical Trial. JAMA Ophthalmol. 2025 May 1;143(5):429-437. doi: 10.1001/jamaophthalmol.2025.0353.

    PMID: 40146119DERIVED

MeSH Terms

Conditions

CataractMacular Degeneration

Interventions

ChocolateGeritol

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRetinal DegenerationRetinal Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 2, 2017

Study Start

June 1, 2015

Primary Completion

May 1, 2022

Study Completion

October 1, 2022

Last Updated

September 17, 2021

Record last verified: 2021-09