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VITAL (Vitamin D and Omega-3 Trial) is a large U.S. primary prevention trial designed to examine whether two widely used supplements lower the incidence of cardiovascular (CV) disease or cancer. Nearly 26,000 middle-aged and older adults (mean age, 67) with no history of CV disease, cancer, or other serious disorders were randomized to receive vitamin D3 (2000 IU daily) or placebo and to receive ω-3 fatty acids or placebo. (We've summarized the results of the ω-3 fatty acid comparison separately [NEJM JW Gen Med Dec 15 and N Engl J Med 2018 Nov 10; (e-pub)]).
At baseline, mean serum 25-hydroxyvitamin D level was 31 ng/mL; at 1 year, mean levels had increased to 42 ng/mL in vitamin D3 recipients and hadn't changed in the placebo group. During…