NCT01212406

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 11, 2015

Status Verified

October 1, 2013

Enrollment Period

2.9 years

First QC Date

September 28, 2010

Last Update Submit

November 10, 2015

Conditions

Allograft RejectionLung TransplantationBronchiolitis Obliterans

Keywords

Organ rejectionLung transplantationBronchiolitis ObliteransVitamin DPrevention

Outcome Measures

Primary Outcomes (2)

  • Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 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 years after transplantation

  • Prevalence of BOS (grade 1) at 3 years after transplantation

    her-evaluation of data

    3 years after transplantation

Secondary Outcomes (5)

  • Bronchoalveolar lavage

    during 2 and 3y of follow-up

  • Peripheral blood

    During 2 and 3 years of follow-up

  • Rejection rates

    During 2 and 3 years of follow-up

  • Reflux

    During 2 and 3 years of follow-up

  • Infection rates

    During 2 and 3 years of follow-up

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Olive oil

Drug: Vitamin D

Vitamin D

EXPERIMENTAL

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

Drug: Vitamin D

Interventions

Vitamin DDRUG

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

Also known as: D-Cure
PlaceboVitamin D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

Related Publications (5)

  • Ramirez AM, Wongtrakool C, Welch T, Steinmeyer A, Zugel U, Roman J. Vitamin D inhibition of pro-fibrotic effects of transforming growth factor beta1 in lung fibroblasts and epithelial cells. J Steroid Biochem Mol Biol. 2010 Feb 15;118(3):142-50. doi: 10.1016/j.jsbmb.2009.11.004. Epub 2009 Nov 17.

    PMID: 19931390BACKGROUND

  • Zittermann A, Schleithoff SS, Gotting C, Fuchs U, Kuhn J, Kleesiek K, Tenderich G, Koerfer R. Calcitriol deficiency and 1-year mortality in cardiac transplant recipients. Transplantation. 2009 Jan 15;87(1):118-24. doi: 10.1097/TP.0b013e31818c2708.

    PMID: 19136901BACKGROUND

  • Janssens W, Bouillon R, Claes B, Carremans C, Lehouck A, Buysschaert I, Coolen J, Mathieu C, Decramer M, Lambrechts D. Vitamin D deficiency is highly prevalent in COPD and correlates with variants in the vitamin D-binding gene. Thorax. 2010 Mar;65(3):215-20. doi: 10.1136/thx.2009.120659. Epub 2009 Dec 8.

    PMID: 19996341BACKGROUND

  • Vanaudenaerde BM, Meyts I, Vos R, Geudens N, De Wever W, Verbeken EK, Van Raemdonck DE, Dupont LJ, Verleden GM. A dichotomy in bronchiolitis obliterans syndrome after lung transplantation revealed by azithromycin therapy. Eur Respir J. 2008 Oct;32(4):832-43. doi: 10.1183/09031936.00134307.

    PMID: 18827151BACKGROUND

  • Estenne M, Maurer JR, Boehler A, Egan JJ, Frost A, Hertz M, Mallory GB, Snell GI, Yousem S. Bronchiolitis obliterans syndrome 2001: an update of the diagnostic criteria. J Heart Lung Transplant. 2002 Mar;21(3):297-310. doi: 10.1016/s1053-2498(02)00398-4. No abstract available.

    PMID: 11897517BACKGROUND

MeSH Terms

Conditions

Bronchiolitis Obliterans

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Geert M Verleden, MD, PhD

    UZ gasthuisberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2010

First Posted

September 30, 2010

Study Start

October 1, 2010

Primary Completion

September 1, 2013

Study Completion

August 1, 2015

Last Updated

November 11, 2015

Record last verified: 2013-10

Locations

BE(1)