Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia
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|ClinicalTrials.gov Identifier: NCT01657656|
Recruitment Status : Completed
First Posted : August 6, 2012
Last Update Posted : July 30, 2014
That improving vitamin D status among TB patients will speed the pace of bacteriological cure, and will enhance immune responses to TB infection
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Supplements Tuberculosis Sputum Cytokines Immunity||Dietary Supplement: Vitamin D||Not Applicable|
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.
We 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.
The 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.
Bacteriologic secondary endpoints, cell-mediated immune function endpoints and BMI.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Vitamin D group
Vitamin D supplement by Tishcon
Dietary Supplement: Vitamin D
Placebo Comparator: Control group
Identically appearing capsules
Dietary Supplement: Vitamin D
- The primary endpoint will be time to sputum culture conversion from positive to negative. [ Time Frame: Eight weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657656
|National Center for Communicable Dieases|