Vitamin D in Bronchiolitis Obliterans Syndrome

Universitaire Ziekenhuizen KU Leuven100 enrolled

Overview

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

* 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Allograft Rejection Lung Transplantation Bronchiolitis Obliterans

Interventions

Vitamin DDRUG

Every month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

UZ Gasthuisberg

Leuven, Belgium

Outcomes

Primary Outcomes

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

Time frame: 2 years after transplantation

Prevalence of BOS (grade 1) at 3 years after transplantation

her-evaluation of data

Time frame: 3 years after transplantation

Secondary Outcomes

Bronchoalveolar lavage

cellularity, protein and mRNA concentration and microbiology

Time frame: during 2 and 3y of follow-up

Peripheral blood

Protein and mRNA concentration, cellularity

Time frame: During 2 and 3 years of follow-up

Rejection rates

Acute rejection and lymphocytic bronchiolitis rates

Time frame: During 2 and 3 years of follow-up

Reflux

clinical and biochemical approach

Time frame: During 2 and 3 years of follow-up

Infection rates

cytomegalovirus (CMV) and non- CMV infection rates

Time frame: During 2 and 3 years of follow-up

Data from ClinicalTrials.gov

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