Vitamin D in Bronchiolitis Obliterans Syndrome (VIT001)

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ClinicalTrials.gov Identifier: NCT01212406

Recruitment Status : Completed

First Posted : September 30, 2010

Last Update Posted : November 11, 2015

Sponsor:

Collaborator:

Katholieke Universiteit Leuven

Information provided by (Responsible Party):

Universitaire Ziekenhuizen Leuven

Study Description

Brief Summary:

Vitamin D deficiency occurs in around 50% of our transplant population. Preventive treatment with Vitamin D (D-cure) can reduce the prevalence of Bronchiolitis Obliterans Syndrome after lung transplantation

Condition or disease	Intervention/treatment	Phase
Allograft Rejection Lung Transplantation Bronchiolitis Obliterans	Drug: Vitamin D	Phase 4

Detailed Description:

Prospective, interventional, randomized, double-blind, placebo-controlled trial.
Clinical setting (tertiary University Hospital).
Investigator-driven, no pharmaceutical sponsor.
Lung transplant recipients.
Add-on of study-drug (placebo or vitamin D) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).
1:1 inclusion ratio (placebo:Vitamin D).
Randomisation at discharge after informed consent.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation
Study Start Date :	October 2010
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Transplantation Vitamin D

Drug Information available for: Vitamin D

Genetic and Rare Diseases Information Center resources: Bronchiolitis Obliterans

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo Olive oil	Drug: Vitamin D Every month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years Other Name: D-Cure
Experimental: Vitamin D Addition of D-cure (100.000U) to standard care	Drug: Vitamin D Every month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years Other Name: D-Cure

Outcome Measures

Primary Outcome Measures :

Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 2 years after transplantation [ Time Frame: 2 years after transplantation ]
BOS= decline in forced expiratory volume in 1 second (FEV1) with at least 80% compared to the best post-operative value
Prevalence of BOS (grade 1) at 3 years after transplantation [ Time Frame: 3 years after transplantation ]
her-evaluation of data

Secondary Outcome Measures :

Bronchoalveolar lavage [ Time Frame: during 2 and 3y of follow-up ]
cellularity, protein and mRNA concentration and microbiology
Peripheral blood [ Time Frame: During 2 and 3 years of follow-up ]
Protein and mRNA concentration, cellularity
Rejection rates [ Time Frame: During 2 and 3 years of follow-up ]
Acute rejection and lymphocytic bronchiolitis rates
Reflux [ Time Frame: During 2 and 3 years of follow-up ]
clinical and biochemical approach
Infection rates [ Time Frame: During 2 and 3 years of follow-up ]
cytomegalovirus (CMV) and non- CMV infection rates

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stable LTx recipients at discharge after transplantation.
Signed informed consent
Adult (age at least 18 years old at moment of transplantation)
Able to take oral medication

Exclusion Criteria:

Prolonged and/or complicated Intensive care unit-course after transplantation.
Early (<30 days post-transplant) post-operative death
Major suture problems (airway stenosis or stent)
Retransplantation (lung)
Previous transplantation (solid organ)
Multi-organ transplantation (lung+ other solid organ)

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): NCT01212406

Locations


Belgium
UZ Gasthuisberg
Leuven, Belgium, 3000

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Katholieke Universiteit Leuven

Investigators


Principal Investigator:	Geert M Verleden, MD, PhD	UZ gasthuisberg

More Information

Publications:

Ramirez AM, Wongtrakool C, Welch T, Steinmeyer A, Zügel U, Roman J. Vitamin D inhibition of pro-fibrotic effects of transforming growth factor beta1 in lung fibroblasts and epithelial cells. J Steroid Biochem Mol Biol. 2010 Feb 15;118(3):142-50. doi: 10.1016/j.jsbmb.2009.11.004. Epub 2009 Nov 17.

Zittermann A, Schleithoff SS, Götting C, Fuchs U, Kuhn J, Kleesiek K, Tenderich G, Koerfer R. Calcitriol deficiency and 1-year mortality in cardiac transplant recipients. Transplantation. 2009 Jan 15;87(1):118-24. doi: 10.1097/TP.0b013e31818c2708.

Janssens W, Bouillon R, Claes B, Carremans C, Lehouck A, Buysschaert I, Coolen J, Mathieu C, Decramer M, Lambrechts D. Vitamin D deficiency is highly prevalent in COPD and correlates with variants in the vitamin D-binding gene. Thorax. 2010 Mar;65(3):215-20. doi: 10.1136/thx.2009.120659. Epub 2009 Dec 8.

Vanaudenaerde BM, Meyts I, Vos R, Geudens N, De Wever W, Verbeken EK, Van Raemdonck DE, Dupont LJ, Verleden GM. A dichotomy in bronchiolitis obliterans syndrome after lung transplantation revealed by azithromycin therapy. Eur Respir J. 2008 Oct;32(4):832-43. doi: 10.1183/09031936.00134307. Review.

Estenne M, Maurer JR, Boehler A, Egan JJ, Frost A, Hertz M, Mallory GB, Snell GI, Yousem S. Bronchiolitis obliterans syndrome 2001: an update of the diagnostic criteria. J Heart Lung Transplant. 2002 Mar;21(3):297-310. Review.


Responsible Party:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT01212406 History of Changes
Other Study ID Numbers:	VIT001
First Posted:	September 30, 2010 Key Record Dates
Last Update Posted:	November 11, 2015
Last Verified:	October 2013

Keywords provided by Universitaire Ziekenhuizen Leuven:


Organ rejection Lung transplantation Bronchiolitis Obliterans Vitamin D Prevention

Additional relevant MeSH terms:


Bronchiolitis Bronchiolitis Obliterans Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections	Vitamins Vitamin D Ergocalciferols Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

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