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). Issue 11 (12th November 2019)

• Record Type: Journal Article
• Authors: Amrein, Karin; Parekh, Dhruv; Westphal, Sabine; Preiser, Jean-Charles; Berghold, Andrea; Riedl, Regina; Eller, Philipp; Schellongowski, Peter; Thickett, David; Meybohm, Patrick
• Other Names: author non-byline.; Marschalek Corinna author non-byline.; Schmutz Rene author non-byline.; Clodi Martin author non-byline.; Resl Michael author non-byline.; Krasser Mario author non-byline.; Michlmayr Matthias author non-byline.; Reisinger Johann author non-byline.; Schiller Alexandra author non-byline.; Verheyen Nicolas Dominik author non-byline.; Lewinski Dirk von author non-byline.; Deininger Marlene Sandra author non-byline.; Muench Andreas author non-byline.; Simonis Holger author non-byline.; Zajic Paul author non-byline.; Lindenau Ines author non-byline.; Eller Philipp author non-byline.; Holl Alexander author non-byline.; Pichler Alexander author non-byline.; Urbanic Purkart Tadeja author non-byline.; Hoffmann Magdalena author non-byline.; Ritsch Katharina author non-byline.; Schmidt Simon author non-byline.; Bellmann Romuald author non-byline.; Brandtner Anna author non-byline.; Ditlbacher Adelheid author non-byline.; Hasslacher Julia author non-byline.; Joannidis Michael author non-byline.; Peer Andreas author non-byline.; Zotter Klemens author non-byline.; Biedermann Christoph Martin author non-byline.; Valentin Andreas author non-byline.; Wimmer Franz author non-byline.; Demschar Susanne author non-byline.; Koestenberger Markus author non-byline.; Likar Rudolf author non-byline.; Neuwersch Stefan author non-byline.; Pogatschnigg Michael author non-byline.; Trummer Brigitte author non-byline.; Duenser Martin author non-byline.; Meier Jens author non-byline.; Kainz Johann author non-byline.; Sommer Romana author non-byline.; Schindler Otmar author non-byline.; Lehr Alexander author non-byline.; Mesaric Guenter author non-byline.; Tinawi Yasmin author non-byline.; Watzinger Norbert author non-byline.; Hammerl Randolf author non-byline.; Krippl Peter author non-byline.; Langner Stefan author non-byline.; Lux Martin author non-byline.; Unteregger Matthias author non-byline.; Fruehauf Gerwig author non-byline.; Gruber Barbara author non-byline.; Harzl Bertram author non-byline.; 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Kranke Peter author non-byline.; Schlesinger Tobias author non-byline.; Kredel Markus author non-byline.; Sitter Magdalena author non-byline.; Stumpner Jan author non-byline.; Schlegel Nico author non-byline.; Schimmer Christoph author non-byline.; Kunze Ekkehard author non-byline.; Kerz Thomas author non-byline.; Wesp Dominik author non-byline.; Neule Axel author non-byline.; Ringel Florian author non-byline.; Stoppe Christian author non-byline.; Maggiorini Mario author non-byline.; Jakob Stephan author non-byline.; Schefold Joerg author non-byline.; Wale Rebekah author non-byline.; Slinn Gemma author non-byline.; Brocklehurst Peter author non-byline.; Jackson Louise author non-byline.; McAuley Danny author non-byline.; Melody Teresa author non-byline.; Patel Jaimin author non-byline.; Perkins Gavin author non-byline.; Ostermann Marlies author non-byline.; Morgan Matthew author non-byline.; Singer Mervyn author non-byline.; Rowland Matthew author non-byline.;
• Is Part Of: BMJ open. Volume 9:Issue 11(2019)
• Publication Date: 2019-11-12
• Subjects: vitamin D -- critically ill patients -- intensive care unit -- vitamin D supplementation -- severe vitamin D deficiency; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-031083
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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.