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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harald Dobnig, MD
• Treatments: Cholecalciferol; Vitamin D

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

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