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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: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Critical Illness
Vitamin D Deficiency
 Drug: Cholecalciferol
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Correction of Vitamin D Deficiency in Critically Ill Patients: a Randomized, Double-blind, Placebo-controlled Trial ("VITDAL@ICU")

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 480
Study Start Date: May 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cholecalciferol 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
Placebo Comparator: Placebo Drug: Placebo
Matching placebo
Other Name: herbal oil

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130181

Locations
Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Harald Dobnig, MD
Investigators
Principal Investigator: Harald Dobnig, MD Medical University of Graz, Austria
  More Information

Publications:

Responsible Party: Harald Dobnig, MD, Professor, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01130181     History of Changes
Other Study ID Numbers: VITdAL@ICU - 19022010
Study First Received: May 21, 2010
Last Updated: October 29, 2012
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Critical Illness
Vitamin D Deficiency
Disease Attributes
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
 Cholecalciferol
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013