Allograft Rejection, Bronchiolitis Obliterans, Lung Transplantation
Conditions
Keywords
Organ rejection, Lung transplantation, Bronchiolitis Obliterans, Vitamin D, Prevention
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.
Interventions
DRUGVitamin D
Every month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Prevalence of BOS (grade 1) at 3 years after transplantation | 3 years after transplantation | her-evaluation of data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rejection rates | During 2 and 3 years of follow-up | Acute rejection and lymphocytic bronchiolitis rates |
| Bronchoalveolar lavage | during 2 and 3y of follow-up | cellularity, protein and mRNA concentration and microbiology |
| Infection rates | During 2 and 3 years of follow-up | cytomegalovirus (CMV) and non- CMV infection rates |
| Reflux | During 2 and 3 years of follow-up | clinical and biochemical approach |
| Peripheral blood | During 2 and 3 years of follow-up | Protein and mRNA concentration, cellularity |
Countries
Belgium
Outcome results
None listed