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Vitamin D, specifically serum 25(OH)D has been associated with mortality, cancer and multiple other health endpoints in observational studies, but there is a paucity of clinical trial evidence sufficient to determine the safety and effectiveness of population-wide supplementation. We have therefore launched the D-Health Trial, a randomized trial of vitamin D supplementation for prevention of mortality and cancer. Here we report the methods and describe the trial cohort.

The D-Health Trial is a randomized placebo-controlled trial, with planned intervention for 5 years and a further 5 years of passive follow-up through linkage with health and death registers. Participants aged 65–84 years were recruited from the general population of Australia. The intervention is monthly oral doses of 60,000 IU of cholecalciferol or matching placebo. The primary outcome is all-cause mortality. Secondary outcomes …