Vitamin D in Bronchiolitis Obliterans Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 23 November 2015
• Main ID: NCT01212406
• Date of registration: 28/09/2010
• Prospective Registration: Yes
• Primary sponsor: Universitaire Ziekenhuizen Leuven
• Public title: Vitamin D in Bronchiolitis Obliterans Syndrome VIT001
• Scientific title: A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation
• Date of first enrolment: October 2010
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01212406
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Belgium

Contacts

• Name: Geert M Verleden, MD, PhD
• Affiliation: UZ gasthuisberg

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bronchiolitis Obliterans

Lung Transplantation

Allograft Rejection

Intervention(s)

Drug: Vitamin D

Primary Outcome(s)

Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 2 years after transplantation [Time Frame: 2 years after transplantation]

Prevalence of BOS (grade 1) at 3 years after transplantation [Time Frame: 3 years after transplantation]

Secondary Outcome(s)

Rejection rates [Time Frame: During 2 and 3 years of follow-up]

Infection rates [Time Frame: During 2 and 3 years of follow-up]

Bronchoalveolar lavage [Time Frame: during 2 and 3y of follow-up]

Reflux [Time Frame: During 2 and 3 years of follow-up]

Peripheral blood [Time Frame: During 2 and 3 years of follow-up]

Secondary ID(s)

VIT001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Katholieke Universiteit Leuven