Vitamin D in Bronchiolitis Obliterans Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2015-08-31

Brief Summary

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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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Detailed Description

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* 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.

Conditions

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Allograft Rejection Lung Transplantation Bronchiolitis Obliterans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Olive oil

Group Type PLACEBO_COMPARATOR

Vitamin D

Intervention Type DRUG

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

Vitamin D

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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D-Cure

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No