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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
Sponsor:
Collaborator:
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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

Condition or disease Intervention/treatment Phase
Allograft Rejection Lung Transplantation Bronchiolitis Obliterans Drug: Vitamin D Phase 4

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.

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
Primary Completion Date : September 2013
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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

  2. Prevalence of BOS (grade 1) at 3 years after transplantation [ Time Frame: 3 years after transplantation ]
    her-evaluation of data


Secondary Outcome Measures :
  1. Bronchoalveolar lavage [ Time Frame: during 2 and 3y of follow-up ]
    cellularity, protein and mRNA concentration and microbiology

  2. Peripheral blood [ Time Frame: During 2 and 3 years of follow-up ]
    Protein and mRNA concentration, cellularity

  3. Rejection rates [ Time Frame: During 2 and 3 years of follow-up ]
    Acute rejection and lymphocytic bronchiolitis rates

  4. Reflux [ Time Frame: During 2 and 3 years of follow-up ]
    clinical and biochemical approach

  5. 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
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)

Information from the National Library of Medicine

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


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

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