Medizinische Universität Graz - Research portal
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SHR Neuro Cancer Cardio Lipid Metab Microb
Amrein, K; Parekh, D; Westphal, S; Preiser, JC; Berghold, A; Riedl, R; Eller, P; Schellongowski, P; Thickett, D; Meybohm, P; VITDALIZE Collaboration Group.
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).
BMJ Open. 2019; 9(11):e031083-e031083
Doi: 10.1136/bmjopen-2019-031083
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- Leading authors Med Uni Graz
- Amrein Karin
- Co-authors Med Uni Graz
- Berghold Andrea
- Eller Philipp
- Riedl Regina
- Study Group Members Med Uni Graz:
- Deininger Marlene Sandra
- Hoffmann Magdalena
- Holl Alexander
- Köstenberger Markus
- Lindenau Ines
- Münch Andreas
- Pichler Alexander
- Ritsch Katharina
- Schmidt Simon
- Simonis Holger
- Urbanic Purkart Tadeja
- Verheyen Nicolas Dominik
- von Lewinski Dirk
- Zajic Paul
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- Abstract:
- 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. 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. 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. NCT03188796, EudraCT-No: 2016-002460-13. © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Cholecalciferol - administration & dosage
- Clinical Trials, Phase III as Topic -
- Critical Illness - mortality
- Double-Blind Method -
- Drug Administration Schedule -
- Female -
- Humans -
- Intensive Care Units -
- Male -
- Multicenter Studies as Topic -
- Randomized Controlled Trials as Topic -
- Vitamin D Deficiency - drug therapy
- Vitamins - administration & dosage