Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-01 @ 3:21 PM
Study NCT ID:
NCT00666367
Status:
COMPLETED
Last Update Posted:
2010-12-24
First Post:
2008-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D as Treatment for Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-23', 'studyFirstSubmitDate': '2008-04-23', 'studyFirstSubmitQcDate': '2008-04-23', 'lastUpdatePostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'median time to next exacerbation.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Total number of exacerbations per group, number of exacerbations per patient per year, percentage of patients with one or more exacerbations per year, days of antibiotics and oral steroids, quality of life, FEV1, muscle force and survival.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '35236342', 'type': 'DERIVED', 'citation': 'Serre J, Tanjeko AT, Mathyssen C, Heigl T, Sacreas A, Cook DP, Verbeken E, Maes K, Verhaegen J, Pilette C, Vanoirbeek J, Gysemans C, Mathieu C, Vanaudenaerde B, Janssens W, Gayan-Ramirez G. Effects of repeated infections with non-typeable Haemophilus influenzae on lung in vitamin D deficient and smoking mice. Respir Res. 2022 Mar 2;23(1):40. doi: 10.1186/s12931-022-01962-6.'}, {'pmid': '22250141', 'type': 'DERIVED', 'citation': 'Lehouck A, Mathieu C, Carremans C, Baeke F, Verhaegen J, Van Eldere J, Decallonne B, Bouillon R, Decramer M, Janssens W. High doses of vitamin D to reduce exacerbations in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2012 Jan 17;156(2):105-14. doi: 10.7326/0003-4819-156-2-201201170-00004.'}]}, 'descriptionModule': {'briefSummary': 'This project aims to explore the relationship between Vitamin D deficiency and COPD progression via a prospective randomized placebo-controlled study. For this purpose, study was powered to 120 patients hospitalized with an exacerbation of COPD randomly assigned to a monthly oral dose of Vitamin D versus placebo. Taking into account dropouts, 182 patients are randomized during the course of the study', 'detailedDescription': 'Principal objective: To define the therapeutic effect of Vitamin D in the chronic maintenance treatment of COPD by means of a prospective randomized placebo-controlled double blind study of 182 patients with a follow-up of at least one year. Primary endpoint is the median time to next exacerbation. Secondary endpoints are total number of exacerbations per group, number of exacerbations per patient per year, percentage of patients with one or more exacerbations per year, days of antibiotics and oral steroids, quality of life, FEV1, muscle force and survival.\n\nOther objectives: First, to investigate the role of local and systemic levels of 25-OHD and 1,25-(OH)2D on the intensity and prevalence of bacterial colonisation, inflammatory markers, proteases and markers of oxidative stress in induced sputa and exhaled air. Second, to explore whether correction of Vitamin D deficiency by the oral supplementation of Vitamin D triggers the VDR-mediated cathelicidin pathway and increases local or systemic concentrations of the natural antimicrobial polypeptide cathelicidin with enhanced eradication of bacteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of COPD exacerbation\n* Smoking history of at least ten pack years\n* GOLD stage II, III and IV as assessed by a post-bronchodilator spirometry\n* Informed consent\n\nExclusion Criteria:\n\n* Tiffeneau index \\>70% or FEV1 \\>80%\n* Hypercalcemia\n* Sarcoidosis\n* Newly discovered symptomatic osteoporosis (proven by DEXA and RX )\n* Active cancer'}, 'identificationModule': {'nctId': 'NCT00666367', 'briefTitle': 'Vitamin D as Treatment for Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'High Dosis of Vitamin D as Treatment for COPD.', 'orgStudyIdInfo': {'id': '2007-004755-11'}, 'secondaryIdInfos': [{'id': 'S50722'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Vitamin D (D-cure) will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study.', 'interventionNames': ['Drug: D-cure']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo will be administered by monthly oral intake. During a prospective follow-up period of one year, the patients will get the normal care with some additional tests for the study.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'D-cure', 'type': 'DRUG', 'otherNames': ['license number: D-cure: 465S37F11'], 'description': '4 ml of D-cure (SMB oral intake) in syringe Exacta-Med Oral Dispenser.', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Product number: Arachidis oleum raffinatum: *FA072892*'], 'description': '4 ml of Arachidis oleum raffinatum Ph. Eur. in syringe Med Oral Dispenser.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Flanders', 'country': 'Belgium', 'facility': 'Katholieke Universiteit Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Flanders', 'country': 'Belgium', 'facility': 'University hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Wim Janssens, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. W. Janssens', 'oldOrganization': 'Katholieke Universiteit Leuven'}}}}