Impact of Vitamin D3 Versus Placebo on Cardiac Structure and Function: A Randomized Clinical Trial

Abstract

Background Vitamin D supplementation leads to regression of left ventricular (LV) hypertrophy and improves LV function in animal models. However, limited data exist from prospective human studies. We examined whether vitamin D supplementation improved cardiac structure and function in midlife/older individuals in a large randomized trial. Methods and Results The VITAL (Vitamin D and OmegA‐3 Trial) was a nationwide double‐blind, placebo‐controlled randomized trial that tested the effects of vitamin D3 (2000 IU/d) and n−3 fatty acids (1 g/d) on cardiovascular and cancer risk in 25 871 individuals aged ≥50 years. We conducted a substudy of VITAL in which participants underwent echocardiography at baseline and 2 years. Images were interpreted by a blinded investigator at a central core laboratory. The primary end point was change in LV mass. Among 1054 Greater Boston–area participants attending in‐clinic visits, we enrolled 1025 into this study. Seventy‐nine percent returned for follow‐up and had analyzable echocardiograms at both visits. At baseline, the median age was 64 years (interquartile range, 60–69 years), 52% were men, and 43% had hypertension. After 2 years, the change in LV mass did not significantly differ between the vitamin D and placebo arms (median +1.4 g versus +2.6 g, respectively; P =0.32). Changes in systolic and diastolic LV function also did not differ significantly between arms. There were no significant changes in cardiac structure and function between the n−3 fatty acids and placebo arms. Conclusions Among adults aged ≥50 years, neither vitamin D3 nor n−3 fatty acids supplementation had significant effects on cardiac structure and function after 2 years. Registration URL: https://clinicaltrials.gov/ ; Unique identifiers: NCT01169259 (VITAL) and NCT01630213 (VITAL‐Echo)