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A randomized placebo-controlled double blind study to prevent BOS - VIT001

A randomized placebo-controlled double blind study to prevent BOS - VIT001

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-022027-30-BE
Enrollment
Unknown
Registered
2010-09-02
Start date
2010-09-23
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A study to prevent the occurence of chronic rejection after lung transplantation. Other points of investigation include lung function evolution, rate of survival, BAL cellularity, infection rate, rate of acute rejection and reflux MedDRA version: 12.1 Level: LLT Classification code 10029888 Term: Obliterative bronchiolitis MedDRA version: 12.1 Level: LLT Classification code 10049202 Term: Bronchiolitis obliterans MedDRA version: 12.1 Level: LLT Classification code 10068805 Term: Follicular br

Interventions

Trade Name: D-Cure Product Name: D-cure Pharmaceutical Form: Oral solution INN or Proposed INN: COLECALCIFEROL CAS Number: 67-97-0 Concentration unit: IU/ml international unit(s)/millilitre Concentrat

Sponsors

UZ Gasthuisberg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Prolonged and/or complicated ICU-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)

Design outcomes

Primary

MeasureTime frame
Main Objective: • Prevalence of BOS (grade 1) at 2 and 3 year post-transplant;Secondary Objective: • BAL: cells (differential cell count, fibrocytes) proteins (IL-17, IL-8, IL-6, LTD4), microbiology • Peripheral blood: CRP and fibrocytes • CMV and non-CMV infection rates • Acute rejection and lymphocytic bronchiolitis rates • Reflux (clinical and biochemical approach) ;Primary end point(s): Development of chronic rejection—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026