Vitamin D in Bronchiolitis Obliterans Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Allograft Rejection, Lung Transplantation, Bronchiolitis Obliterans

Intervention / Treatment
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* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Olive oil | Drug: Vitamin D<br>* Every month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years<br>* Other names: D-Cure;|
| Experimental: Vitamin D<br>Addition of D-cure (100.000U) to standard care | Drug: Vitamin D<br>* Every month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years<br>* Other names: D-Cure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Prevalence of BOS (grade 1) at 3 years after transplantation | her-evaluation of data | 3 years after transplantation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Organ rejection, Lung transplantation, Bronchiolitis Obliterans, Vitamin D, Prevention