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Vitamin D in Bronchiolitis Obliterans Syndrome — VIT001  

Lung Transplantation Clinical Trial

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

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01212406
Study type Interventional
Source Universitaire Ziekenhuizen Leuven
Contact
Status Completed
Phase Phase 4
Start date October 2010
Completion date August 2015
View Details
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