Effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients with severe vitamin D deficiency: a study protocol of a multicentre, placebo-controlled double-blind phase III RCT (the VITDALIZE study)
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Colleges, School and Institutes
- Research Unit for Experimental and Molecular Hepatology, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz, Austria.
- Intensive Care Medicine, Erasme University Hospital, Brussels, Belgium.
- Institute for Medical Informatics, Statstics, and Documentation, Medical University of Graz, Graz, Austria.
- Intensive Care Unit, Department of Internal Medicine, University Hospital of Graz, Graz, Austria.
- University Hospital of Internal Medicine I, Medical University Wien, Wien, Austria.
- Birmingham Acute Care Research Group, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
- e School of Clinical and Experimental Medicine , Institute of Clinical Sciences , University of Birmingham , Birmingham , UK.
- Department of Anesthesiology, University Hospital Wuerzburg, Wuerzburg, Germany.
INTRODUCTION: Observational studies have demonstrated an association between vitamin D deficiency and increased risk of morbidity and mortality in critically ill patients. Cohort studies and pilot trials have suggested promising beneficial effects of vitamin D replacement in the critical ill, at least in patients with severe vitamin D deficiency. As vitamin D is a simple, low-cost and safe intervention, it has potential to improve survival in critically ill patients.
METHODS AND ANALYSIS: In this randomised, placebo-controlled, double-blind, multicentre, international trial, 2400 adult patients with severe vitamin D deficiency (25-hydroxyvitamin D≤12 ng/mL) will be randomised in a 1:1 ratio by www.randomizer.at to receive a loading dose of 540 000 IU cholecalciferol within 72 hours after intensive care unit (ICU) admission, followed by 4000 IU daily for 90 days or placebo. Hypercalcaemia may occur as a side effect, but is monitored by regular checks of the calcium level. The primary outcome is all-cause mortality at 28 days after randomisation. Secondary outcomes are: ICU, hospital, 90-day and 1-year mortality; hospital and ICU length of stay, change in organ dysfunction on day 5 as measured by Sequential Organ Function Assessment (SOFA) score, number of organ failures; hospital and ICU readmission until day 90; discharge destination, self-reported infections requiring antibiotics until day 90 and health-related quality of life. Recruitment status is ongoing.
ETHICS AND DISSEMINATION: National ethical approval was obtained by the Ethics Committee of the University of Graz for Austria, Erasme University Brussels (Belgium) and University Hospital Frankfurt (Germany), and will further be gained according to individual national processes. On completion, results will be published in a peer-reviewed scientific journal. The study findings will be presented at national and international meetings with abstracts online.
TRIAL REGISTRATION: NCT03188796, EudraCT-No: 2016-002460-13.
|Publication status||Published - 12 Nov 2019|