Vitamin D in Bronchiolitis Obliterans Syndrome

Lung Transplantation Clinical Trial

— VIT001  

Official title:

A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212406
• Other study ID #: VIT001
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: November 10, 2015
• Start date: October 2010
• Est. completion date: August 2015

Study information

• Verified date: October 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allograft Rejection
• Bronchiolitis
• Bronchiolitis Obliterans
• Lung Transplantation

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 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 years after transplantation	No
Primary	Prevalence of BOS (grade 1) at 3 years after transplantation	her-evaluation of data	3 years after transplantation	No
Secondary	Bronchoalveolar lavage	cellularity, protein and mRNA concentration and microbiology	during 2 and 3y of follow-up	No
Secondary	Peripheral blood	Protein and mRNA concentration, cellularity	During 2 and 3 years of follow-up	No
Secondary	Rejection rates	Acute rejection and lymphocytic bronchiolitis rates	During 2 and 3 years of follow-up	No
Secondary	Reflux	clinical and biochemical approach	During 2 and 3 years of follow-up	No
Secondary	Infection rates	cytomegalovirus (CMV) and non- CMV infection rates	During 2 and 3 years of follow-up	No