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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01130181
First Posted: May 25, 2010
Last Update Posted: May 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Harald Dobnig, MD, Medical University of Graz
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Harald Dobnig, MD, Medical University of Graz:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: 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:
  • 25(OH)D levels [ Time Frame: maximum 6 months ]
    serum 25(OH)D levels will be measured on day 0, 3 and 7

  • calcium levels [ Time Frame: maximum 6 months ]
    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 ]
  • duration of mechanical ventilation [ Time Frame: starting from application of study medication ]
    duration of mechanical ventilation including CPAP/mask ventilation

  • hospital mortality, 28-day mortality, 6 month-mortality [ Time Frame: maximum 6 months ]

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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Lee P, Eisman JA, Center JR. Vitamin D deficiency in critically ill patients. N Engl J Med. 2009 Apr 30;360(18):1912-4. doi: 10.1056/NEJMc0809996. Erratum in: N Engl J Med. 2011 May 12;364(19):1882.
Lucidarme O, Messai E, Mazzoni T, Arcade M, du Cheyron D. Incidence and risk factors of vitamin D deficiency in critically ill patients: results from a prospective observational study. Intensive Care Med. 2010 Sep;36(9):1609-11. doi: 10.1007/s00134-010-1875-8. Epub 2010 Apr 7.
Lee P, Nair P, Eisman JA, Center JR. Vitamin D deficiency in the intensive care unit: an invisible accomplice to morbidity and mortality? Intensive Care Med. 2009 Dec;35(12):2028-32. doi: 10.1007/s00134-009-1642-x. Epub 2009 Sep 15. Review.
Mata-Granados JM, Vargas-Vasserot J, Ferreiro-Vera C, Luque de Castro MD, Pavón RG, Quesada Gómez JM. Evaluation of vitamin D endocrine system (VDES) status and response to treatment of patients in intensive care units (ICUs) using an on-line SPE-LC-MS/MS method. J Steroid Biochem Mol Biol. 2010 Jul;121(1-2):452-5. doi: 10.1016/j.jsbmb.2010.03.078. Epub 2010 Apr 21.
Krishnan A, Ochola J, Mundy J, Jones M, Kruger P, Duncan E, Venkatesh B. Acute fluid shifts influence the assessment of serum vitamin D status in critically ill patients. Crit Care. 2010;14(6):R216. doi: 10.1186/cc9341. Epub 2010 Nov 26.
Amrein K, Venkatesh B. Vitamin D and the critically ill patient. Curr Opin Clin Nutr Metab Care. 2012 Mar;15(2):188-93. doi: 10.1097/MCO.0b013e32834f0027. Review.
Braun AB, Gibbons FK, Litonjua AA, Giovannucci E, Christopher KB. Low serum 25-hydroxyvitamin D at critical care initiation is associated with increased mortality. Crit Care Med. 2012 Jan;40(1):63-72. doi: 10.1097/CCM.0b013e31822d74f3.
Amrein K, Schnedl C, Berghold A, Pieber TR, Dobnig H. Correction of vitamin D deficiency in critically ill patients - VITdAL@ICU study protocol of a double-blind, placebo-controlled randomized clinical trial. BMC Endocr Disord. 2012 Nov 7;12:27. doi: 10.1186/1472-6823-12-27.
Amrein K, Zajic P, Schnedl C, Waltensdorfer A, Fruhwald S, Holl A, Purkart T, Wünsch G, Valentin T, Grisold A, Stojakovic T, Amrein S, Pieber TR, Dobnig H. Vitamin D status and its association with season, hospital and sepsis mortality in critical illness. Crit Care. 2014 Mar 24;18(2):R47. doi: 10.1186/cc13790.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harald Dobnig, MD, Professor, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01130181     History of Changes
Other Study ID Numbers: VITdAL@ICU - 19022010
First Submitted: May 21, 2010
First Posted: May 25, 2010
Last Update Posted: May 28, 2014
Last Verified: May 2014

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


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