NCT01212406

Vitamin D in Bronchiolitis Obliterans Syndrome

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allograft Rejection
• Lung Transplantation
• Bronchiolitis Obliterans

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-09-01
• Completion: 2015-08-01
• First posted: 2010-09-30
• Last updated: 2015-11-11

Locations

1 site across 1 country: Belgium