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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Harald Dobnig, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01130181
First received: May 21, 2010
Last updated: May 23, 2014
Last verified: May 2014

May 21, 2010
May 23, 2014
May 2010
September 2012   (final data collection date for primary outcome measure)
Length of hospital stay [ Time Frame: maximum 6 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01130181 on ClinicalTrials.gov Archive Site
  • 25(OH)D levels [ Time Frame: maximum 6 months ] [ Designated as safety issue: Yes ]
    serum 25(OH)D levels will be measured on day 0, 3 and 7
  • calcium levels [ Time Frame: maximum 6 months ] [ Designated as safety issue: Yes ]
    serum calcium levels will be measured on day 0, 3 and 7
  • length of ICU stay starting from application of study medication [ Time Frame: until patient's death or referral to another ward ] [ Designated as safety issue: No ]
  • duration of mechanical ventilation [ Time Frame: starting from application of study medication ] [ Designated as safety issue: No ]
    duration of mechanical ventilation including CPAP/mask ventilation
  • hospital mortality, 28-day mortality, 6 month-mortality [ Time Frame: maximum 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
VITdAL@ICU - Correction of Vitamin D Deficiency in Critically Ill Patients
Correction of Vitamin D Deficiency in Critically Ill Patients: a Randomized, Double-blind, Placebo-controlled Trial ("VITDAL@ICU")

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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Critical Illness
  • Vitamin D Deficiency
  • Drug: Cholecalciferol
    loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU
    Other Name: cholecalciferol
  • Drug: Placebo
    Matching placebo
    Other Name: herbal oil
  • Experimental: Cholecalciferol
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01130181
VITdAL@ICU - 19022010
Yes
Harald Dobnig, MD, Medical University of Graz
Harald Dobnig, MD
Not Provided
Principal Investigator: Harald Dobnig, MD Medical University of Graz, Austria
Medical University of Graz
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP