The VITamin D and OmegA-3 TriaL (VITAL): Do Results Differ by Sex or Race/Ethnicity?

Whether vitamin D or marine omega-3 (n-3) fatty acid supplementation reduces risk of cancer or cardiovascular disease (CVD) in general populations at usual risk for these outcomes is relatively unexplored in randomized trials. The primary goal of the VITamin D and OmegA-3 TriaL (VITAL), a nationwide, randomized, placebo-controlled, 2 × 2 factorial trial of vitamin D₃ (2000 IU/day) and marine n-3 fatty acids (1 g/day) in the primary prevention of cancer and CVD among 25 871 US men aged ≥50 years and women aged ≥55 years, was to fill these knowledge gaps. Studying the influence of sex and race/ethnicity on treatment-related outcomes was a prespecified goal; such analyses help ensure that important effects are not missed and contribute to the foundation for developing targeted recommendations for supplement use. To enable investigation of potential sex- and race-specific treatment effects, trial investigators enrolled an even balance of men (n = 12 786) and women (n = 13 085) and oversampled African Americans (n = 5106). Significant or suggestive variation in intervention effects according to sex, race/ethnicity, and other participant characteristics was observed for some, though not all, outcomes. Additional research is needed to determine which individuals may be most likely to derive a net benefit from vitamin D or n-3 fatty acid supplementation. (VITAL clinicaltrials.gov identifier: NCT01169259).