Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-02-03 @ 4:37 PM
Study NCT ID:
NCT00419068
Status:
COMPLETED
Last Update Posted:
2009-09-30
First Post:
2007-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Adjunctive Vitamin D in Tuberculosis Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-29', 'studyFirstSubmitDate': '2007-01-05', 'studyFirstSubmitQcDate': '2007-01-05', 'lastUpdatePostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to sputum culture conversion'}], 'secondaryOutcomes': [{'measure': 'Rate of bacillary kill'}, {'measure': '2-month culture conversion rate'}, {'measure': 'Time to sputum smear conversion'}, {'measure': 'Weight change'}, {'measure': 'Radiographic response'}]}, 'conditionsModule': {'conditions': ['Tuberculosis, Pulmonary']}, 'referencesModule': {'references': [{'pmid': '21215445', 'type': 'DERIVED', 'citation': 'Martineau AR, Timms PM, Bothamley GH, Hanifa Y, Islam K, Claxton AP, Packe GE, Moore-Gillon JC, Darmalingam M, Davidson RN, Milburn HJ, Baker LV, Barker RD, Woodward NJ, Venton TR, Barnes KE, Mullett CJ, Coussens AK, Rutterford CM, Mein CA, Davies GR, Wilkinson RJ, Nikolayevskyy V, Drobniewski FA, Eldridge SM, Griffiths CJ. High-dose vitamin D(3) during intensive-phase antimicrobial treatment of pulmonary tuberculosis: a double-blind randomised controlled trial. Lancet. 2011 Jan 15;377(9761):242-50. doi: 10.1016/S0140-6736(10)61889-2. Epub 2011 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected smear positive pulmonary tuberculosis.\n* Age 18 years or older.\n* Written informed consent to participate.\n\nExclusion Criteria:\n\n* Known intolerance of vitamin D or first-line anti-tuberculous therapy.\n* Taking antituberculous therapy for more than six days in the six months preceding enrolment.\n* Taking the following medication in the month preceding enrolment: oral corticosteroid therapy, immunosuppressant therapy or cytotoxic therapy.\n* Taking the following medication at enrolment: benzothiadiazine derivatives, cardiac glycosides or antituberculous therapy other than rifampicin, isoniazid, pyrazinamide and ethambutol.\n* Diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, HIV infection, liver failure, renal failure or malignancy\n* Infection with rifampicin-resistant organism (as demonstrated by rapid molecular testing)\n* Biochemical disturbance at enrolment: serum corrected calcium \\>2.66 mmol/l, serum AST \\>120 IU/l, total serum bilirubin \\> 40 micromol/l or serum creatinine \\> 250 micromol/l\n* Breastfeeding or pregnancy'}, 'identificationModule': {'nctId': 'NCT00419068', 'briefTitle': 'Trial of Adjunctive Vitamin D in Tuberculosis Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'Trial of Adjunctive Vitamin D in Tuberculosis Treatment', 'orgStudyIdInfo': {'id': '2005-003562-42'}, 'secondaryIdInfos': [{'id': 'EudraCT no: 2005-003562-42'}, {'id': 'REC ref: 06/Q0605/83'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cholecalciferol', 'type': 'DRUG'}, {'name': 'Migliol Placebo Oil', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E11 1NR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Whipps Cross University Hospital NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'E13 8SL', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Newham University Hospital NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'E2 9JX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'London Chest Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'E9 6SR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Homerton University Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Adrian R Martineau, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary University of London'}, {'name': 'Christopher J Griffiths, FRCP FRCGP D Phil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary University of London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'British Lung Foundation', 'class': 'OTHER'}]}}}