Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-02-20 @ 6:21 PM
Study NCT ID:
NCT00157066
Status:
COMPLETED
Last Update Posted:
2007-01-08
First Post:
2005-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Vitamin D Supplementation on Antimycobacterial Immunity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D055985', 'term': 'Latent Tuberculosis'}], 'ancestors': [{'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': 'D000085343', 'term': 'Latent Infection'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004872', 'term': 'Ergocalciferols'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2006-09'}, 'lastUpdateSubmitDate': '2007-01-05', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2007-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacillus Calmette-Guerin (BCG) lux whole blood assay'}], 'secondaryOutcomes': [{'measure': 'Antigen-stimulated whole blood interferon gamma production'}]}, 'conditionsModule': {'keywords': ['Latent tuberculosis infection', 'Active tuberculosis infection'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '17463418', 'type': 'DERIVED', 'citation': 'Martineau AR, Wilkinson RJ, Wilkinson KA, Newton SM, Kampmann B, Hall BM, Packe GE, Davidson RN, Eldridge SM, Maunsell ZJ, Rainbow SJ, Berry JL, Griffiths CJ. A single dose of vitamin D enhances immunity to mycobacteria. Am J Respir Crit Care Med. 2007 Jul 15;176(2):208-13. doi: 10.1164/rccm.200701-007OC. Epub 2007 Apr 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Tuberculosis (TB) contact or TB patient\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding\n* Hyperparathyroidism\n* Sarcoidosis\n* Renal failure\n* HIV infection'}, 'identificationModule': {'nctId': 'NCT00157066', 'briefTitle': 'Effects of Vitamin D Supplementation on Antimycobacterial Immunity', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'Effects of Vitamin D Supplementation on Antimycobacterial Immunity: A Randomised Trial', 'orgStudyIdInfo': {'id': 'AM1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ergocalciferol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E7 8QP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Tuberculosis Clinic, Newham Chest Clinic', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Adrian R Martineau, B Med Sci, MBBS, DTM&H, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Health Sciences, Barts and The London, QMUL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College London', 'class': 'OTHER'}, {'name': 'University of Cape Town', 'class': 'OTHER'}, {'name': 'Newham Chest Clinic, London E7 8QP, UK', 'class': 'UNKNOWN'}, {'name': 'Northwick Park Hospital, Harrow, UK', 'class': 'OTHER'}, {'name': 'Department of Clinical Biochemistry, Homerton Hospital, London E9 6SR, UK', 'class': 'OTHER'}, {'name': 'Environmental Health Department, London Borough of Newham, London E15 4SF, UK', 'class': 'UNKNOWN'}, {'name': 'Wellcome Trust', 'class': 'OTHER'}]}}}