Critically ill patients with vitamin D deficiency
Conditions
Interventions
Trade Name: Oleovit D3
Product Name: Oleovit D3
Pharmaceutical Form: Oral drops*
Pharmaceutical form of the placebo: Oral drops*
Route of administration of the placebo: Oral use
Sponsors
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: Process optimisation for the subsequent study is another important goal in this pilot trial. ;Primary end point(s): Percentage of patients with 25(OH)D = 30 ng/ml at day 7 | — |
Countries
Austria
Outcome results
None listed