Vitamin D in Bronchiolitis Obliterans Syndrome

Phase 4

Completed

• Conditions: Allograft Rejection; Lung Transplantation; Bronchiolitis Obliterans
• Interventions: Drug: Vitamin D

• Registration Number: NCT01212406
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

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 Timeline

• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Study Start: 2010-10
• Primary Completion: 2013-09
• Status Verified: 2013-10
• Study Completion: 2015-08
• Last Update Submitted: 2015-11-10
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Vitamin D	Olive oil
Vitamin D	Vitamin D	Addition of D-cure (100.000U) to standard care

Primary Outcome Measures

Name	Time	Method
Prevalence of BOS (grade 1) at 3 years after transplantation	3 years after transplantation	her-evaluation of data
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UZ Gasthuisberg; 🇧🇪 Leuven, Belgium