Tuberculosis Clinical Trial
Official title:
Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia
Hypothesis
That improving vitamin D status among TB patients will speed the pace of bacteriological
cure, and will enhance immune responses to TB infection
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.
Secondary Endpoints:
Bacteriologic secondary endpoints, cell-mediated immune function endpoints and BMI.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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