Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-29 @ 4:50 AM
Study NCT ID:
NCT01212406
Status:
COMPLETED
Last Update Posted:
2015-11-11
First Post:
2010-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D in Bronchiolitis Obliterans Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}], 'ancestors': [{'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-10', 'studyFirstSubmitDate': '2010-09-28', 'studyFirstSubmitQcDate': '2010-09-29', 'lastUpdatePostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Bronchiolitis Obliterans syndrome (BOS) (grade 1) at 2 years after transplantation', 'timeFrame': '2 years after transplantation', 'description': 'BOS= decline in forced expiratory volume in 1 second (FEV1) with at least 80% compared to the best post-operative value'}, {'measure': 'Prevalence of BOS (grade 1) at 3 years after transplantation', 'timeFrame': '3 years after transplantation', 'description': 'her-evaluation of data'}], 'secondaryOutcomes': [{'measure': 'Bronchoalveolar lavage', 'timeFrame': 'during 2 and 3y of follow-up', 'description': 'cellularity, protein and mRNA concentration and microbiology'}, {'measure': 'Peripheral blood', 'timeFrame': 'During 2 and 3 years of follow-up', 'description': 'Protein and mRNA concentration, cellularity'}, {'measure': 'Rejection rates', 'timeFrame': 'During 2 and 3 years of follow-up', 'description': 'Acute rejection and lymphocytic bronchiolitis rates'}, {'measure': 'Reflux', 'timeFrame': 'During 2 and 3 years of follow-up', 'description': 'clinical and biochemical approach'}, {'measure': 'Infection rates', 'timeFrame': 'During 2 and 3 years of follow-up', 'description': 'cytomegalovirus (CMV) and non- CMV infection rates'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Organ rejection', 'Lung transplantation', 'Bronchiolitis Obliterans', 'Vitamin D', 'Prevention'], 'conditions': ['Allograft Rejection', 'Lung Transplantation', 'Bronchiolitis Obliterans']}, 'referencesModule': {'references': [{'pmid': '19931390', 'type': 'BACKGROUND', 'citation': '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': '19136901', 'type': 'BACKGROUND', 'citation': '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': '19996341', 'type': 'BACKGROUND', 'citation': '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': '18827151', 'type': 'BACKGROUND', 'citation': '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': '11897517', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "* Prospective, interventional, randomized, double-blind, placebo-controlled trial.\n* Clinical setting (tertiary University Hospital).\n* Investigator-driven, no pharmaceutical sponsor.\n* Lung transplant recipients.\n* Add-on of study-drug (placebo or vitamin D) to 'standard of care' (standardized, routine immunosuppressive and infectious prophylactic protocol).\n* 1:1 inclusion ratio (placebo:Vitamin D).\n* Randomisation at discharge after informed consent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable LTx recipients at discharge after transplantation.\n* Signed informed consent\n* Adult (age at least 18 years old at moment of transplantation)\n* Able to take oral medication\n\nExclusion Criteria:\n\n* Prolonged and/or complicated Intensive care unit-course after transplantation.\n* Early (\\<30 days post-transplant) post-operative death\n* Major suture problems (airway stenosis or stent)\n* Retransplantation (lung)\n* Previous transplantation (solid organ)\n* Multi-organ transplantation (lung+ other solid organ)'}, 'identificationModule': {'nctId': 'NCT01212406', 'acronym': 'VIT001', 'briefTitle': 'Vitamin D in Bronchiolitis Obliterans Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'A Randomized Double Blind Placebo Controlled Trial With Vitamin D to Prevent Bronchiolitis Obliterans Syndrome After Lung Transplantation', 'orgStudyIdInfo': {'id': 'VIT001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Olive oil', 'interventionNames': ['Drug: Vitamin D']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D', 'description': 'Addition of D-cure (100.000U) to standard care', 'interventionNames': ['Drug: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'otherNames': ['D-Cure'], 'description': 'Every month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years', 'armGroupLabels': ['Placebo', 'Vitamin D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Geert M Verleden, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ gasthuisberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'KU Leuven', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}