Vitamin D in Bronchiolitis Obliterans Syndrome (VIT001)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01212406
First received: September 28, 2010
Last updated: December 13, 2013
Last verified: October 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    her-evaluation of data


Secondary Outcome Measures:
  • Bronchoalveolar lavage [ Time Frame: during 2 and 3y of follow-up ] [ Designated as safety issue: No ]
    cellularity, protein and mRNA concentration and microbiology

  • Peripheral blood [ Time Frame: During 2 and 3 years of follow-up ] [ Designated as safety issue: No ]
    Protein and mRNA concentration, cellularity

  • Rejection rates [ Time Frame: During 2 and 3 years of follow-up ] [ Designated as safety issue: No ]
    Acute rejection and lymphocytic bronchiolitis rates

  • Reflux [ Time Frame: During 2 and 3 years of follow-up ] [ Designated as safety issue: No ]
    clinical and biochemical approach

  • Infection rates [ Time Frame: During 2 and 3 years of follow-up ] [ Designated as safety issue: No ]
    cytomegalovirus (CMV) and non- CMV infection rates


Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (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
Genders Eligible for Study:   Both
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
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: December 13, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ethics Committee

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
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014