IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: 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 |
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 September 21, 2017