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Completed

NCT Number: NCT01212406

Vitamin D in Bronchiolitis Obliterans Syndrome

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

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Key information

Conditions

Allograft Rejection Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchitis Lung Diseases Lung Diseases, Obstructive Lung Transplantation Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UZ Gasthuisberg

Leuven, 3000, Belgium

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin D

Drug

Every month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years

Other names: D-Cure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study title

A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation

Acronym: VIT001

Important dates

Study start
2010
Primary completion
2013
Study completion
2015
First posted
Sep 30, 2010
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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