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

Critical Illness Clinical Trial

— VITdAL@ICU  

Official title:

Correction of Vitamin D Deficiency in Critically Ill Patients: a Randomized, Double-blind, Placebo-controlled Trial ("VITDAL@ICU")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130181
• Other study ID #: VITdAL@ICU - 19022010
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2010
• Last updated: May 23, 2014
• Start date: May 2010
• Est. completion date: September 2012

Study information

• Verified date: May 2014
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU
• Placebo
Matching placebo

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Harald Dobnig, MD

Country where clinical trial is conducted

Austria, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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