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Correction of vitamin D deficiency in critically ill patients: a randomized, doulbe-blind, placebo-controlled trial

Conditions
Critically ill patients with vitamin D deficiency
Registration Number
EUCTR2010-018798-39-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
480
Inclusion Criteria

- Age = 18 years
- Expected ICU stay = 48 hours
- Vitamin D deficiency: 25(OH)D = 20ng/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
- Hypercalcaemia (toal calcium > 2.65 or ionised calcium > 1,35mmol/L)
- Severly impaired gastrointestinal motility (ileus, gastric residual volume > 400ml)
- pregnancy
- Known history of recent nephrolithiasis (= 1 year)
-Known granulomatous diseases (tuberculosis, sarcoidosis)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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