VIT001: Vitamin D in Bronchiolitis Obliterans Syndrome

• Sponsor: Universitaire Ziekenhuizen Leuven (Other)
• Overall Status: Completed
• CT.gov ID: NCT01212406
• Collaborator: KU Leuven (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 58
• Patients Per Site Per Month: 1.7

Study Details

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
• 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: Oct 1, 2010
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Aug 1, 2015

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 Names: 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 Names: D-Cure

Outcome Measures

Primary Outcome Measures

1. Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 2 years after transplantation [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

2. Prevalence of BOS (grade 1) at 3 years after transplantation [3 years after transplantation]

   her-evaluation of data

Secondary Outcome Measures

1. Bronchoalveolar lavage [during 2 and 3y of follow-up]

   cellularity, protein and mRNA concentration and microbiology

2. Peripheral blood [During 2 and 3 years of follow-up]

   Protein and mRNA concentration, cellularity

3. Rejection rates [During 2 and 3 years of follow-up]

   Acute rejection and lymphocytic bronchiolitis rates

4. Reflux [During 2 and 3 years of follow-up]

   clinical and biochemical approach

5. Infection rates [During 2 and 3 years of follow-up]

   cytomegalovirus (CMV) and non- CMV infection rates

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	UZ Gasthuisberg	Leuven		Belgium	3000

Sponsors and Collaborators

• Universitaire Ziekenhuizen Leuven
• KU Leuven

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Universitaire Ziekenhuizen Leuven
• ClinicalTrials.gov Identifier: NCT01212406
• Other Study ID Numbers: VIT001
• First Posted: Sep 30, 2010
• Last Update Posted: Nov 11, 2015
• Last Verified: Oct 1, 2013

• Keywords provided by Universitaire Ziekenhuizen Leuven: Organ rejection; Lung transplantation; Bronchiolitis Obliterans; Vitamin D; Prevention
• Additional relevant MeSH terms: Bronchiolitis; Bronchiolitis Obliterans; Vitamin D

Study Results

No Results Posted as of Nov 11, 2015