Phase 4
Completed N=21,442
COcoa Supplement and Multivitamin Outcomes Study
Source: ClinicalTrials.gov NCT02422745 ↗Enrolled (actual)
21,442
Serious AEs
12.8%
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants With Total Cardiovascular Disease (CVD) Events — 410; 456; 429; 437 Participants
◆ Published Evidence
Established
50citations · ~13 / year
Multivitamins in the prevention of cancer and cardiovascular disease: the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial.
Summary
The purpose of this study is to determine whether taking daily, dietary supplements of cocoa extract (containing cocoa flavanols and theobromine from the cocoa bean) and/or a standard multivitamin reduces the risk of developing cardiovascular disease (including heart attack, stroke, coronary revascularization, unstable angina or acute coronary syndrome (ACS) requiring hospitalization, carotid artery surgery, and peripheral artery surgery or angioplasty, and cardiovascular mortality) and cancer.
Linked Publications (5)
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Multivitamins in the prevention of cancer and cardiovascular disease: the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial.
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Effect of multivitamin-mineral supplementation versus placebo on cognitive function: results from the clinic subcohort of the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial and meta-analysis of 3 cognitive studies within COSMOS.
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Effect of cocoa extract supplementation on cognitive function: results from the clinic subcohort of the COSMOS trial.
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Long-Term Effect of Multivitamin Supplementation on Incident Self-Reported Hypertension and Blood Pressure Changes in the COSMOS Trial.
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Effects of daily multivitamin-multimineral supplementation on metabolomic profiles: 2-year findings from the COSMOS randomized clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Total Cardiovascular Disease (CVD) Events |
410; 456; 429; 437 | — |
| PRIMARY Number of Participants With Invasive Cancer Events |
550; 503; 518; 535 | — |
| SECONDARY Number of Participants With Composite Endpoint of MI, Stroke, Cardiovascular Mortality, and Coronary Revascularization |
362; 403; 381; 384 | — |
| SECONDARY Number of Participants With Total Cardiovascular Events Plus All-Cause Mortality |
665; 731; 680; 716 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
88; 101; 96; 93 | — |
| SECONDARY Number of Participants With Stroke |
113; 124; 121; 116 | — |
| SECONDARY Number of Participants With Cardiovascular Mortality |
76; 104; 84; 96 | — |
| SECONDARY Number of Participants With Coronary Revascularization |
166; 175; 177; 164 | — |
| SECONDARY Number of Participants With Unstable Angina or Acute Coronary Syndrome Requiring Hospitalization |
46; 46; 50; 42 | — |
| SECONDARY Number of Participants With Carotid Artery Surgery |
25; 27; 24; 28 | — |
| SECONDARY Number of Participants With Peripheral Artery Surgery or Angioplasty |
17; 19; 16; 20 | — |
| SECONDARY Number of Participants With Total Mortality |
353; 397; 362; 388 | — |
| SECONDARY Number of Participants With Breast Cancer |
99; 81; 93; 87 | — |
| SECONDARY Number of Participants With Colorectal Cancer |
38; 29; 38; 29 | — |
| SECONDARY Number of Participants With Lung Cancer |
49; 58; 41; 66 | — |
| SECONDARY Median Urinary gVLM Levels at Year 2 Among Those Providing Spot Urine at Baseline and Year 2 |
10.3; 2.9; 5.9; 5.3 | — |
Eligibility Criteria
Inclusion Criteria
- Women ≥ 65 years of age participating in the Women's Health Initiative (WHI) Extension Study.
- Men ≥ 60 years of age and women age ≥ 65 years of age who were contacted for but not randomized into the VITAL trial.
- Other women ≥ 65 years of age and men aged ≥ 60 years of age who responded to targeted mass mailings and volunteers who learned about the trial through the media or through ResearchMatch.org, an electronic recruitment website.
- Willing to participate, as evidenced by providing informed consent and completing all required baseline forms.
Exclusion Criteria
- History of myocardial infarction or stroke.
- Diagnosed with invasive cancer other than non-melanoma skin cancer in the last 2 years prior to enrollment.
- Any serious illness that would preclude participation and/or completion of the trial, including the diagnosis of kidney failure and current dialysis treatment.
- Taking cocoa extract or multivitamin supplements and not willing to forego use during the trial.
- Taking total supplemental vitamin D > 1,000 IU/day and not willing to forego use during the trial.
- Taking total supplemental calcium > 1, 200 mg/day and not willing to forego use during the trial.
- Extreme sensitivity to caffeine.
- Consume < 75% of the expected number of both types of supplements during the run-in phase.
- Unable to communicate in English due to language barrier or mental incapacity.
Data sourced from ClinicalTrials.gov (NCT02422745) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.