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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
Sponsor:
Information provided by (Responsible Party):
Ganmaa Davaasambuu, Harvard School of Public Health

Brief Summary:

Hypothesis

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

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vitamin D group
Vitamin D supplement by Tishcon
Dietary Supplement: Vitamin D
Placebo Comparator: Control group
Identically appearing capsules
Dietary Supplement: Vitamin D



Primary Outcome Measures :
  1. The primary endpoint will be time to sputum culture conversion from positive to negative. [ Time Frame: Eight weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Mongolia
National Center for Communicable Dieases
Ulaanbaatar, Mongolia
Sponsors and Collaborators
Harvard School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ganmaa Davaasambuu, Assistant Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01657656     History of Changes
Other Study ID Numbers: R00HL089710 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2012    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vitamins
Vitamin D
Ergocalciferols
Antitubercular Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Bacterial Agents
Anti-Infective Agents