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Cocoa extract + multivitamin for Cardiovascular Disease (COSMOS Trial)
Phase 4
Waitlist Available
Led By JoAnn E. Manson, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
COSMOS Trial Summary
This trial will test whether taking cocoa extract and/or a multivitamin daily reduces the risk of developing cardiovascular disease or cancer.
Eligible Conditions
- Cardiovascular Disease
- Cancer
COSMOS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiovascular disease (CVD) events
Invasive cancer
Secondary outcome measures
Blood flavonoid levels
Breast cancer
Cardiovascular mortality
+11 moreOther outcome measures
Body composition
Bone mass density in hip, spine, and total body, and body composition
Physical performance
+2 moreCOSMOS Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Cocoa extract + multivitamin placeboActive Control2 Interventions
Group II: Cocoa extract placebo + multivitaminActive Control2 Interventions
Group III: Cocoa extract + multivitaminActive Control2 Interventions
Group IV: Cocoa extract placebo + multivitamin placeboPlacebo Group2 Interventions
Find a Location
Who is running the clinical trial?
Mars, Inc.Industry Sponsor
19 Previous Clinical Trials
5,082 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,609 Previous Clinical Trials
11,448,885 Total Patients Enrolled
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,890,432 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You take more than 1,200mg of calcium supplements per day and are unwilling to stop taking them during the study.You currently take more than 1,000 IU of vitamin D per day and are not willing to stop taking it during the trial.Women who are 65 years or older and men who are 60 years or older who volunteered to participate in the study after learning about it through mail, media or a recruitment website called ResearchMatch.org.You are extremely sensitive to caffeine.You regularly take cocoa extract or multivitamin supplements and are not willing to stop using them during the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Cocoa extract placebo + multivitamin placebo
- Group 2: Cocoa extract + multivitamin placebo
- Group 3: Cocoa extract placebo + multivitamin
- Group 4: Cocoa extract + multivitamin
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA allow patients to take Cocoa extract + multivitamin?
"The safety of Cocoa extract + multivitamin is rated as a 3 by our team. This is due to the fact that this is a Phase 4 trial, which means that this treatment has been approved."
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