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VITdAL@ICU - Correction of Vitamin D Deficiency in Critically Ill Patients — VITdAL@ICU  

Critical Illness Clinical Trial

Official title:
Correction of Vitamin D Deficiency in Critically Ill Patients: a Randomized, Double-blind, Placebo-controlled Trial ("VITDAL@ICU")

Clinical Trial Summary

Study hypothesis:

High-dose vitamin D leads to a shorter hospital stay in critically ill patients

Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol or placebo.

Clinical Trial Description

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

Exclusion criteria

- moribund patient expected to die within 24 hours

- hypercalcaemia (total calcium >2.65 OR ion. calcium >1.35 mmol/l)

- severely impaired gastrointestinal motility (ileus, residual gastric volume > 400 ml)

- known history of recent kidney stones (≤ 1 year)

- known granulomatous diseases (tuberculosis, sarcoidosis)

- pregnancy

Primary endpoint

- hospital stay (hours; starting from ICU admission) Secondary endpoints

- percentage of patients with 25(OH)D ≥ 30 ng/ml at day 7

- serum calcium; phosphorus; 25(OH)D; 1,25(OH)D; PTH; osteocalcin; bALP; TRAP; urinary calcium ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01130181
Study type Interventional
Source Medical University of Graz
Contact
Status Completed
Phase Phase 3
Start date May 2010
Completion date September 2012
View Details
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