An interventional study of Vitamin D in Vitamin D Supplements, Tuberculosis and Sputum, sponsored by Harvard School of Public Health (HSPH). Completed at 1 site in Mongolia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-07-30.
Sponsored by Harvard School of Public Health (HSPH) · Not applicable, Interventional, and Treatment
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 350 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitamin D supplement by Tishcon
Dietary Supplement: Vitamin D
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
The record gives a start of Oct 2012, a primary completion of May 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin D
Harvard School of Public Health (HSPH) →