Effect of 25-hydroxy vitamin D on inflammation and bone-turnover in critically ill patients

ISRCTN	ISRCTN24385496
DOI	https://doi.org/10.1186/ISRCTN24385496
Secondary identifying numbers	ITE vitamin D study (2)

Submission date: 10/04/2009
Registration date: 23/04/2009
Last edited: 23/04/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Greet Van den Berghe
Scientific

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

Phone	+32 (0)16 344021
Email	Greet.VandenBerghe@med.kuleuven.be

Study information

Study design	Blinded prospective randomised controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Institutional Review Board of the Catholic University of Leuven School of Medicine approved on the 25th November 2003 (ref: ML2462)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	12/01/2004
Completion date	02/09/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	24 patients: 12 per arm (+ 24 matched healthy control samples)
Key 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
Key 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
Date of first enrolment	12/01/2004
Date of final enrolment	02/09/2004

Locations

Countries of recruitment

Belgium

Study participating centre

Director of the Department of Intensive Care Medicine

Leuven
3000
Belgium

Sponsor information

Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)
University/education

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

Email	Koenraad.Debackere@abh.kuleuven.be
Website	http://www.kuleuven.ac.be/english/index.htm
"ROR"	https://ror.org/05f950310

Funders

Funder type

University/education

Catholic University Leuven (Katholieke Universiteit Leuven) (Belgium)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan