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Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ganmaa Davaasambuu, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01657656
First received: August 2, 2012
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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 Intervention
Vitamin D Supplements
Tuberculosis
Sputum
Cytokines
Immunity
Dietary Supplement: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementations as Adjunct to Anti-Tuberculosis Drugs in Mongolia

Resource links provided by NLM:


Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • The primary endpoint will be time to sputum culture conversion from positive to negative. [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: October 2012
Study Completion Date: July 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D group
Vitamin D supplement by Tishcon
Dietary Supplement: Vitamin D
Placebo Comparator: Control group
Identically appearing capsules
Dietary Supplement: Vitamin D

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01657656

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

No publications provided

Responsible Party: Ganmaa Davaasambuu, Assistant Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT01657656     History of Changes
Other Study ID Numbers: R00HL089710
Study First Received: August 2, 2012
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014