Vitamin D in Bronchiolitis Obliterans Syndrome (VIT001)
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ClinicalTrials.gov Identifier: NCT01212406 |
Recruitment Status
:
Completed
First Posted
: September 30, 2010
Last Update Posted
: November 11, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allograft Rejection Lung Transplantation Bronchiolitis Obliterans | Drug: Vitamin D | Phase 4 |
- 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 (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (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 |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
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
|
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212406
Belgium | |
UZ Gasthuisberg | |
Leuven, Belgium, 3000 |
Principal Investigator: | Geert M Verleden, MD, PhD | UZ gasthuisberg |
Publications:
Responsible Party: | Universitaire Ziekenhuizen Leuven |
ClinicalTrials.gov Identifier: | NCT01212406 History of Changes |
Other Study ID Numbers: |
VIT001 |
First Posted: | September 30, 2010 Key Record Dates |
Last Update Posted: | November 11, 2015 |
Last Verified: | October 2013 |
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 |