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
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

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 Obliterans
Bronchiolitis
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
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014