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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 23, 2014
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 August 28, 2014