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Vitamin D in Bronchiolitis Obliterans Syndrome (VIT001)
This study has been completed.
Sponsor:
Universitaire Ziekenhuizen Leuven
Collaborator:
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01212406
First received: September 28, 2010
Last updated: November 10, 2015
Last verified: October 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Allograft Rejection Lung Transplantation Bronchiolitis Obliterans | Drug: Vitamin D | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation |
Resource links provided by NLM:
Further study details as provided by Universitaire Ziekenhuizen Leuven:
Primary Outcome Measures:
- Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 2 years after transplantation [ Time Frame: 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 [ Time Frame: 3 years after transplantation ]her-evaluation of data
Secondary Outcome Measures:
- Bronchoalveolar lavage [ Time Frame: during 2 and 3y of follow-up ]cellularity, protein and mRNA concentration and microbiology
- Peripheral blood [ Time Frame: During 2 and 3 years of follow-up ]Protein and mRNA concentration, cellularity
- Rejection rates [ Time Frame: During 2 and 3 years of follow-up ]Acute rejection and lymphocytic bronchiolitis rates
- Reflux [ Time Frame: During 2 and 3 years of follow-up ]clinical and biochemical approach
- Infection rates [ Time Frame: During 2 and 3 years of follow-up ]cytomegalovirus (CMV) and non- CMV infection rates
| Enrollment: | 100 |
| Study Start Date: | October 2010 |
| Study Completion Date: | August 2015 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Olive oil
|
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
Other Name: D-Cure
|
|
Experimental: Vitamin D
Addition of D-cure (100.000U) to standard care
|
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
Other Name: D-Cure
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01212406
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212406
Locations
| Belgium | |
| UZ Gasthuisberg | |
| Leuven, Belgium, 3000 | |
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Katholieke Universiteit Leuven
Investigators
| Principal Investigator: | Geert M Verleden, MD, PhD | UZ gasthuisberg |
More Information
Publications:
| Responsible Party: | Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01212406 History of Changes |
| Other Study ID Numbers: |
VIT001 |
| Study First Received: | September 28, 2010 |
| Last Updated: | November 10, 2015 |
Keywords provided by Universitaire Ziekenhuizen Leuven:
|
Organ rejection Lung transplantation Bronchiolitis Obliterans Vitamin D Prevention |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchiolitis Obliterans Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections |
Vitamins Vitamin D Ergocalciferols Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on July 27, 2017