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

Tracking Information

First Received Date ^ICMJE

May 21, 2010

Last Updated Date

October 29, 2012

Start Date ^ICMJE

May 2010

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01130181 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Critical Illness
Vitamin D Deficiency

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Cholecalciferol
Intervention: Drug: Cholecalciferol
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

480

Completion Date

September 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT01130181

Other Study ID Numbers ^ICMJE

VITdAL@ICU - 19022010

Has Data Monitoring Committee

Yes

Responsible Party

Harald Dobnig, MD, Medical University of Graz

Study Sponsor ^ICMJE

Harald Dobnig, MD

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Harald Dobnig, MD

Medical University of Graz, Austria

Information Provided By

Medical University of Graz

Verification Date

October 2012

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

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