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

This study is currently recruiting participants.
Verified December 2013 by Harvard School of Public Health
Sponsor:
Information provided by (Responsible Party):
Ganmaa Davaasambuu, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01657656
First received: August 2, 2012
Last updated: December 16, 2013
Last verified: December 2013
  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
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657656

Contacts
Contact: Ganmaa Davaasambuu, M.D, Ph.D (617) 432 5553 gdavaasa@hsph.harvard.edu

Locations
Mongolia
National Center for Communicable Dieases Recruiting
Ulaanbaatar, Mongolia
Contact: Ganmaa Davaasambuu, MD, PhD    617 432 5553    gdavaasa@hsph.harvard.edu   
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: December 16, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014