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

Phase 3

Completed

• Conditions: Vitamin D Deficiency; Critical Illness
• Interventions: Drug: Cholecalciferol; Drug: Placebo

• Registration Number: NCT01130181
• Lead Sponsor: Harald Dobnig, MD

Brief 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.

Detailed 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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-25
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-23
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecalciferol	Cholecalciferol	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	maximum 6 months	The length of hospital stay will be compared between the two groups (starting from application of the study medication; end is defined as death of the patient or hospital discharge) Survivors and non-survivors will also be analysed separately. Stay in rehabilitation facilities will not be counted.

Secondary Outcome Measures

Name	Time	Method
25(OH)D levels	maximum 6 months	serum 25(OH)D levels will be measured on day 0, 3 and 7
calcium levels	maximum 6 months	serum calcium levels will be measured on day 0, 3 and 7
hospital mortality, 28-day mortality, 6 month-mortality	maximum 6 months
length of ICU stay starting from application of study medication	until patient's death or referral to another ward
duration of mechanical ventilation	starting from application of study medication	duration of mechanical ventilation including CPAP/mask ventilation

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria