(OR19-02-26) Multivitamin-Mineral Supplementation Modestly Improves Cardiovascular-Related Functional Health Status in Older Adults: Secondary Findings From the COSMOS Trial

Objectives: Declines in cardiovascular-related functional health status are common with aging, yet the long‑term effects of randomized multivitamin–mineral (MVM) and cocoa extract (CE) supplementation on patient‑reported outcomes remain unclear in older adults. This secondary analysis of the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) examined whether daily MVM or CE influenced Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in generally healthy older adults and those with preexisting heart conditions.

Methods: COSMOS was a 2×2 factorial, randomized, double‑blind, placebo‑controlled trial of 21,442 U.S. adults (men ≥60, women ≥65 years) without major cardiovascular disease at baseline. We analyzed 16,027 participants with complete annual KCCQ assessments over 3 years. KCCQ outcomes included physical ability score (PAS), comprising six items assessing the ability to perform activities such as dressing, bathing, walking, climbing stairs, and household chores; symptom burden (SB), including fatigue, swelling, and shortness of breathing; and clinical summary score (CSS), the average of PAS and SB. Linear mixed‑effects models and subgroup analyses were conducted.

Results: Among 16,027 participants, those randomized to a daily MVM produced small but statistically significant improvements in SB (mean difference [MD] 0.63; 95% CI 0.23–1.02; P=0.002), no effect in PAS, and an overall improvement in CSS (MD 0.43; 95% CI 0.12–0.73; P=0.006). Further, clinically meaningful benefits were observed in participants with carotid stenosis (n=122, MD 7.58; 95% CI 2.40–12.75; P<sub>interaction < 0.001). CE did not improve outcomes overall, but preserved SB in those with heart failure (n=238, MD 5.62; 95% CI 0.68–10.57; P<sub>interaction=0.001).

Conclusions: This is the first large randomized clinical trial to evaluate the long‑term effects of MVM and CE supplementation on KCCQ cardiovascular functional health outcomes in older adults. Our results provide new evidence that a daily MVM modestly improved cardiovascular-related functional health status, with more pronounced benefits in those with existing carotid stenosis, underscoring the need for future targeted clinical trials.

Funding Sources: This work is supported by HL157665 to YD and HSD from the National Institutes of Health, Bethesda, MD.