Journal article

A randomized placebo-controlled trial of vitamin D supplementation for reduction of mortality and cancer: Statistical analysis plan for the D-Health Trial

Mary Waterhouse, Dallas R English, Bruce K Armstrong, Catherine Baxter, Briony Duarte Romero, Peter R Ebeling, Gunter Hartel, Michael G Kimlin, Donald SA McLeod, Rachel L O'Connell, Jolieke C van der Pols, Alison J Venn, Penelope M Webb, David C Whiteman, Rachel E Neale

Contemporary Clinical Trials Communications | ELSEVIER INC | Published : 2019

Abstract

Background: Many observational studies have reported an association between vitamin D and non-skeletal health outcomes. The D-Health Trial was launched to determine if supplementing the older population with high monthly doses of Vitamin D can prevent cancer and premature mortality. The intervention is ongoing but here we provide a detailed statistical analysis plan for the primary and secondary outcomes of the D-Health Trial. Methods/design: The D-Health Trial is a double-blind, randomized, placebo-controlled trial. Between February 2014 and May 2015, 21,315 people were randomized in a 1:1 ratio to receive monthly doses of either 60,000 IU of cholecalciferol (vitamin D3) or placebo for five..

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Grants

Awarded by National Health and Medical Research Council


Funding Acknowledgements

The D-Health Trial is funded by a National Health and Medical Research Council project grant (APP1046681). RE Neale, DSA McLeod, PM Webb and DC Whiteman are supported by fellowships from the NHMRC.