Vitamin D in Bronchiolitis Obliterans Syndrome (VIT001)

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Bronchiolitis Obliterans; Lung Transplantation; Allograft Rejection

Treatments: Drug: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01212406

VIT001

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Olive oil

Treatment:

Drug: Vitamin D

Vitamin D

Experimental group

Description:

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

Treatment:

Drug: Vitamin D