Innovation in the design of large-scale hybrid randomized clinical trials

Rist, Pamela M.; Sesso, Howard D.; Manson, JoAnn E.

doi:10.1016/j.cct.2020.106178

Cited by 5 publications

(1 citation statement)

References 33 publications

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“…The COSMOS trial has several key strengths, including the enrollment of a large, older population of US adults with high rates of follow-up and compliance and medical record–adjudicated primary and secondary cancer and CVD outcomes. Utilizing a hybrid trial design ( 67 ), several ancillary studies are examining the effect of an MVM on cognition, eye health, changes in aging-related biomarkers, falls, and other clinically relevant outcomes to help us understand the overall balance of risks and benefits for MVM supplementation. Finally, we tested a commonly used MVM supplement to ensure broader generalizability of our findings.…”

Section: Discussionmentioning

confidence: 99%

Multivitamins in the prevention of cancer and cardiovascular disease: the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) randomized clinical trial

Sesso

Rist

Aragaki

et al. 2022

The American Journal of Clinical Nutrition

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Background Although older adults commonly take multivitamin-multimineral (MVM) supplements to promote health, evidence on use of daily MVMs on invasive cancer is limited. Objectives The study objective was to determine if a daily MVM decreases total invasive cancer among older adults. Methods We performed a randomized, double-blind, placebo-controlled, two-by-two factorial trial of a daily MVM and cocoa extract for prevention of cancer and cardiovascular disease (CVD) among 21,442 U.S. adults (12,666 women aged ≥ 65 years and 8776 men aged ≥ 60 years) free of major CVD and recently diagnosed cancer. The intervention phase was from June 2015 through December 2020. This article reports on the MVM intervention. Intervention Participants were randomly assigned to daily MVM or placebo. The primary outcome was total invasive cancer, excluding non-melanoma skin cancer. Secondary outcomes included major site-specific cancers, total CVD, all-cause mortality, and total cancer risk among those with a baseline history of cancer. Results During a median follow-up of 3.6 years, invasive cancer occurred in 518 participants in the MVM group and 535 participants in the placebo group (hazard ratio [HR]=0.97, 95% confidence interval [CI]: 0.86, 1.09; P = 0.57). We observed no significant effect of a daily MVM on breast cancer (HR = 1.06, 95% CI: 0.79, 1.42) or colorectal cancer (HR = 1.30, 95% CI: 0.80, 2.12). We observed a protective effect of a daily MVM on lung cancer (HR = 0.62, 95% CI: 0.42, 0.92). The composite CVD outcome occurred in 429 participants in the MVM group and 437 participants in the placebo group (HR = 0.98, 95% CI: 0.86, 1.12). MVM did not significantly affect all-cause mortality (HR = 0.93; 95% CI: 0.81,1.08). There were no safety concerns. Conclusion A daily MVM supplement, compared with placebo, did not significantly reduce the incidence of total cancer among older men and women. Future studies are needed to determine the effects of MVMs on other aging-related outcomes among older adults.

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Section: Discussionmentioning

confidence: 99%