Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 10:38 AM
Study NCT ID:
NCT01657656
Status:
COMPLETED
Last Update Posted:
2014-07-30
First Post:
2012-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': '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'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-29', 'studyFirstSubmitDate': '2012-08-02', 'studyFirstSubmitQcDate': '2012-08-03', 'lastUpdatePostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint will be time to sputum culture conversion from positive to negative.', 'timeFrame': 'Eight weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Vitamin D Supplements', 'Tuberculosis', 'Sputum', 'Cytokines', 'Immunity']}, 'referencesModule': {'references': [{'pmid': '28692301', 'type': 'DERIVED', 'citation': 'Ganmaa D, Munkhzul B, Fawzi W, Spiegelman D, Willett WC, Bayasgalan P, Baasansuren E, Buyankhishig B, Oyun-Erdene S, Jolliffe DA, Xenakis T, Bromage S, Bloom BR, Martineau AR. High-Dose Vitamin D3 during Tuberculosis Treatment in Mongolia. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Sep 1;196(5):628-637. doi: 10.1164/rccm.201705-0936OC.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis\n\nThat improving vitamin D status among TB patients will speed the pace of bacteriological cure, and will enhance immune responses to TB infection', 'detailedDescription': "Tuberculosis (TB) will be the world's largest single cause of death from infection for the 30-year period between 1990 and 2020. More than 95% of TB cases, and deaths due to TB, occur in developing countries. Mongolia is one of the countries with the highest tuberculosis burdens in the Western Pacific region. In addition, vitamin D deficiency is endemic in Mongolia. We propose to determine the efficacy of vitamin D supplements, as an adjunct to multidrug therapy, in enhancing the anti-microbial immune response to TB, a finding that could lead to the development of shorter drug regimens, and thus more efficient and effective TB treatment protocols.\n\nWe propose to conduct a double blind, placebo controlled, randomized clinical trial to test the effect of a daily vitamin D supplementation on the ability of subjects to control TB infection.\n\nThe Primary Endpoint: The primary endpoint will be: time to sputum culture conversion from positive to negative. The number of days to sputum conversion will be measured, in both the intervention and control groups, starting on the date that treatment is begun. Sputum samples will be collected and cultured every two weeks thereafter. The date of conversion from positive to negative, for each subject, will be the date halfway between the date of the last culture-positive sputum and the first culture-negative one.\n\nSecondary Endpoints:\n\nBacteriologic secondary endpoints, cell-mediated immune function endpoints and BMI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sputum positive TB patients\n\nExclusion Criteria:\n\n* We will exclude those with abnormal LFTs at baseline (2.5 times upper limit of normal), as they will be at higher risk of developing drug-induced hepatitis'}, 'identificationModule': {'nctId': 'NCT01657656', 'briefTitle': 'Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia', 'orgStudyIdInfo': {'id': 'R00HL089710', 'link': 'https://reporter.nih.gov/quickSearch/R00HL089710', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D group', 'description': 'Vitamin D supplement by Tishcon', 'interventionNames': ['Dietary Supplement: Vitamin D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Identically appearing capsules', 'interventionNames': ['Dietary Supplement: Vitamin D']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Control group', 'Vitamin D group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulaanbaatar', 'country': 'Mongolia', 'facility': 'National Center for Communicable Dieases', 'geoPoint': {'lat': 47.90771, 'lon': 106.88324}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ganmaa Davaasambuu', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}