Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/04/2009
Date assigned
23/04/2009
Last edited
23/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Greet Van den Berghe

ORCID ID

Contact details

Director of the Department of Intensive Care Medicine
Catholic University Leuven
University Hospitals
Chair of the Division of Acute Medical Sciences
Catholic University Leuven
Herestraat 49
Leuven
3000
Belgium
+32 (0)16 344021
Greet.VandenBerghe@med.kuleuven.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ITE vitamin D study (2)

Study information

Scientific title

Effect of 25-hydroxy vitamin D on inflammation and bone-turnover in critically ill patients: a blinded, prospective, randomised, controlled, parallel group trial

Acronym

Study hypothesis

In prolonged critically ill patients, rapid and full normalisation of the vitamin D status (25(OH)D levels) with 25(OH)D supplements will result in less inflammation and improved calcium and bone metabolism, compared to placebo.

Ethics approval

Institutional Review Board of the Catholic University of Leuven School of Medicine approved on the 25th November 2003 (ref: ML2462)

Study design

Blinded prospective randomised controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Inflammation/calcium and bone metabolism

Intervention

Informed consent will be requested from the next of kin (closest family member or legal guardian) before inclusion in the study. The family member or the patient can withdraw from the trial, at any time, without impact on his treatment or penalty. The investigators confirm that this study concerns a condition that directly threatens patient health and that the adult patient not able to give consent suffers from the condition. The experiment is essential to confirm the results from earlier research in patients who could consent or from other research methods.

Upon ICU admission, patients will be randomly allocated to either:
1. The currently advised vitamin D supplement (a daily intravenous [IV] cholecalciferol supplement of ± 200 IU as part of 10 ml of Cernevit (Clinitec-Baxter, Brussels, Belgium) and a daily IV injection of placebo (ethanol 1 ml)
2. The currently advised vitamin D supplement, an IV loading dose of 200 µg and an IV maintenance dose of 15 µg/day of 25(OH)D, from ICU admission onward and continued for 10 days

25(OH)D will be obtained from Solvay Pharmaceuticals and will be dissolved in ethanol by the hospital pharmacy under laminar flow conditions in glass vials, containing 200 µg/1 ml per vial for the loading dose and 15 µg/1 ml per vial for the maintenance dose. A purity control has been performed on the prepared samples using HPLC (official certificate in addendum). Placebo vials will be prepared by the hospital pharmacy (1 ml ethanol per vial). The vials will be blinded by the hospital pharmacy.

Parenteral nutrition will be given according to routine clinical practice aiming for 25 non-protein calories per kg bodyweight per day and enteral nutrition will be attempted as early as possible.

Intervention type

Supplement

Phase

Not Applicable

Drug names

25-hydroxy vitamin D

Primary outcome measures

1. Inflammation and innate immunity patterns, daily during study period (from day 0 till day 10)
2. Bone turnover and vitamin D status: via blood and urine analyses, daily during study period (from day 0 till day 10)

Secondary outcome measures

1. Infections, during ICU stay: from admission untill ICU discharge
2. Organ function: Apache (measured upon ICU admission) and Sequential Organ Failure Assessment (SOFA) (measured daily during study period [from day 0 till day 10]) scores
3. ICU stay, measured upon discharge
4. Mortality (ICU, hospital), measured during ICU stay and hospital stay

Overall trial start date

12/01/2004

Overall trial end date

02/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients admitted to any of the four intensive care units with an anticipated Intensive Care Unit (ICU) stay of greater than 10 days
2. Older than 18 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24 patients: 12 per arm (+ 24 matched healthy control samples)

Participant exclusion criteria

1. Younger than 18 years
2. Patients suffering from chronic bone disease
3. Patients suffering from parathyroid disease
4. Patients suffering from chronic kidney disease
5. Patients known to be pregnant or nursing
6. Prior treated with glucocorticoids before ICU admission
7. Patients with a 'do not resuscitate' (DNR) code at the time of ICU admission
8. Patients already enrolled in another trial

Recruitment start date

12/01/2004

Recruitment end date

02/09/2004

Locations

Countries of recruitment

Belgium

Trial participating centre

Director of the Department of Intensive Care Medicine
Leuven
3000
Belgium

Sponsor information

Organisation

Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)

Sponsor details

c/o Professor Dr Ir Koenraad Debackere
Managing Director
Leuven Research and Development
Minderbroedersstraat 8A - bus 5105
Leuven
3000
Belgium
Koenraad.Debackere@abh.kuleuven.be

Sponsor type

University/education

Website

http://www.kuleuven.ac.be/english/index.htm

Funders

Funder type

University/education

Funder name

Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Research Foundation Flanders (Fonds Wetnschappelijk Onderzoek-Vlaanderen [FWO]) (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes