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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01657656 |
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Date of registration:
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02/08/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia
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Scientific title:
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Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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350 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01657656 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Mongolia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Sputum positive TB patients
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Immunity
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Sputum
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Vitamin D Supplements
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Tuberculosis
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Cytokines
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Intervention(s)
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Dietary Supplement: Vitamin D
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Primary Outcome(s)
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The primary endpoint will be time to sputum culture conversion from positive to negative.
[Time Frame: Eight weeks]
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Secondary ID(s)
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R00HL089710
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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