Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
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SHR Neuro Krebs Kardio Lipid Stoffw Microb
Amrein, K; Schnedl, C; Berghold, A; Pieber, TR; Dobnig, H.
Correction of vitamin D deficiency in critically ill patients - VITdAL@ICU study protocol of a double-blind, placebo-controlled randomized clinical trial.
BMC Endocr Disord. 2012; 12(11):27-27
Doi: 10.1186/1472-6823-12-27
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- Führende Autor*innen der Med Uni Graz
- Amrein Karin
- Dobnig Harald
- Co-Autor*innen der Med Uni Graz
- Berghold Andrea
- Pieber Thomas
- Schnedl Christian
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- Abstract:
- Vitamin D deficiency is associated with multiple adverse health outcomes including increased morbidity and mortality in the general population and in critically ill patients. However, no randomized controlled trial has evaluated so far whether treatment with sufficiently large doses of vitamin D can improve clinical outcome of patients in an intensive care setting. The VITdAL@ICU trial is an investigator-initiated, non-commercial, double-blind, placebo-controlled randomized clinical trial. This study compares high-dose oral cholecalciferol (vitamin D3) versus placebo treatment in a mixed population of 480 critically ill patients with low 25-hydroxyvitamin-D levels at study enrollment (≤ 20ng/ml). Following an initial loading dose of 540,000 IU of vitamin D3, patients receive 90,000 IU of vitamin D3 on a monthly basis for 5 months. The study is designed to compare clinical outcome in the two study arms with the primary endpoint being length of hospital stay. Secondary endpoints include among others length of ICU stay, the percentage of patients with 25(OH)D levels > 30 ng/ml at day 7, ICU and hospital mortality and duration of mechanical ventilation. We describe here the VITdAL@ICU study protocol for the primary report. This trial is designed to evaluate whether high-dose vitamin D3 is able to improve morbidity and mortality in a mixed population of adult critically ill patients and correct vitamin D deficiency safely. ClinicalTrials: NCT01130181.
- Find related publications in this database (Keywords)
- Critical Illness
- Vitamin D deficiency
- Cholecalciferol
- Vitamin D
- Critical care
- Intensive care
- Vitamin D3