VITDAL@ICU - Vitamin D supplementation in critically ill patients – prospective, double-blind, randomized, placebo-controlled trial (pilot study) - VITDAL@IC
- Conditions
- Critically ill patients with vitamin D deficiency
- Registration Number
- EUCTR2009-012080-34-AT
- Lead Sponsor
- Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Age =18 years
- expected ICU stay = 48 hours
- vitamin D deficiency: 25(OH)D = 20 ng/ml
- feasibility of study drug application via nasogastric tube in cases where
oral food intake is not possible
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- moribund patient expected to die within 24 hours
- admission diagnosis septic shock”
- hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l)
- severely impaired gastrointestinal motility (ileus, necessary nasogastric
suction tube)
- known history of recent nephrolithiasis (= 1 year)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to investigate whether oral high-dose vitamin D leads to sufficient vitamin D serum levels in ICU patients within one week.<br>;Secondary Objective: Process optimisation for the subsequent study is another important goal in this pilot trial. <br>;Primary end point(s): Percentage of patients with 25(OH)D = 30 ng/ml at day 7
- Secondary Outcome Measures
Name Time Method