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Vitamin D in Bronchiolitis Obliterans Syndrome (VIT001)

Primary Purpose

Allograft Rejection, Lung Transplantation, Bronchiolitis Obliterans

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Allograft Rejection focused on measuring Organ rejection, Lung transplantation, Bronchiolitis Obliterans, Vitamin D, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UZ Gasthuisberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Vitamin D

Arm Description

Olive oil

Addition of D-cure (100.000U) to standard care

Outcomes

Primary Outcome Measures

Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 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
her-evaluation of data

Secondary Outcome Measures

Bronchoalveolar lavage
cellularity, protein and mRNA concentration and microbiology
Peripheral blood
Protein and mRNA concentration, cellularity
Rejection rates
Acute rejection and lymphocytic bronchiolitis rates
Reflux
clinical and biochemical approach
Infection rates
cytomegalovirus (CMV) and non- CMV infection rates

Full Information

First Posted
September 28, 2010
Last Updated
November 10, 2015
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01212406
Brief Title
Vitamin D in Bronchiolitis Obliterans Syndrome
Acronym
VIT001
Official Title
A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allograft Rejection, Lung Transplantation, Bronchiolitis Obliterans
Keywords
Organ rejection, Lung transplantation, Bronchiolitis Obliterans, Vitamin D, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Olive oil
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Addition of D-cure (100.000U) to standard care
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
D-Cure
Intervention Description
Every month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years
Primary Outcome Measure Information:
Title
Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 2 years after transplantation
Description
BOS= decline in forced expiratory volume in 1 second (FEV1) with at least 80% compared to the best post-operative value
Time Frame
2 years after transplantation
Title
Prevalence of BOS (grade 1) at 3 years after transplantation
Description
her-evaluation of data
Time Frame
3 years after transplantation
Secondary Outcome Measure Information:
Title
Bronchoalveolar lavage
Description
cellularity, protein and mRNA concentration and microbiology
Time Frame
during 2 and 3y of follow-up
Title
Peripheral blood
Description
Protein and mRNA concentration, cellularity
Time Frame
During 2 and 3 years of follow-up
Title
Rejection rates
Description
Acute rejection and lymphocytic bronchiolitis rates
Time Frame
During 2 and 3 years of follow-up
Title
Reflux
Description
clinical and biochemical approach
Time Frame
During 2 and 3 years of follow-up
Title
Infection rates
Description
cytomegalovirus (CMV) and non- CMV infection rates
Time Frame
During 2 and 3 years of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert M Verleden, MD, PhD
Organizational Affiliation
UZ gasthuisberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
19931390
Citation
Ramirez AM, Wongtrakool C, Welch T, Steinmeyer A, Zugel U, Roman J. Vitamin D inhibition of pro-fibrotic effects of transforming growth factor beta1 in lung fibroblasts and epithelial cells. J Steroid Biochem Mol Biol. 2010 Feb 15;118(3):142-50. doi: 10.1016/j.jsbmb.2009.11.004. Epub 2009 Nov 17.
Results Reference
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PubMed Identifier
19136901
Citation
Zittermann A, Schleithoff SS, Gotting C, Fuchs U, Kuhn J, Kleesiek K, Tenderich G, Koerfer R. Calcitriol deficiency and 1-year mortality in cardiac transplant recipients. Transplantation. 2009 Jan 15;87(1):118-24. doi: 10.1097/TP.0b013e31818c2708.
Results Reference
background
PubMed Identifier
19996341
Citation
Janssens W, Bouillon R, Claes B, Carremans C, Lehouck A, Buysschaert I, Coolen J, Mathieu C, Decramer M, Lambrechts D. Vitamin D deficiency is highly prevalent in COPD and correlates with variants in the vitamin D-binding gene. Thorax. 2010 Mar;65(3):215-20. doi: 10.1136/thx.2009.120659. Epub 2009 Dec 8.
Results Reference
background
PubMed Identifier
18827151
Citation
Vanaudenaerde BM, Meyts I, Vos R, Geudens N, De Wever W, Verbeken EK, Van Raemdonck DE, Dupont LJ, Verleden GM. A dichotomy in bronchiolitis obliterans syndrome after lung transplantation revealed by azithromycin therapy. Eur Respir J. 2008 Oct;32(4):832-43. doi: 10.1183/09031936.00134307.
Results Reference
background
PubMed Identifier
11897517
Citation
Estenne M, Maurer JR, Boehler A, Egan JJ, Frost A, Hertz M, Mallory GB, Snell GI, Yousem S. Bronchiolitis obliterans syndrome 2001: an update of the diagnostic criteria. J Heart Lung Transplant. 2002 Mar;21(3):297-310. doi: 10.1016/s1053-2498(02)00398-4. No abstract available.
Results Reference
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Vitamin D in Bronchiolitis Obliterans Syndrome

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