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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657656
• Other study ID #: R00HL089710
• Status: Completed
• Phase: N/A
• First received: August 2, 2012
• Last updated: July 29, 2014
• Start date: October 2012
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytokines
• Immunity
• Sputum
• Tuberculosis
• Vitamin D Supplements

Intervention

Dietary Supplement:
• Vitamin D

Locations

Country	Name	City	State
Mongolia	National Center for Communicable Dieases	Ulaanbaatar

Sponsors (1)

Lead Sponsor	Collaborator
Harvard School of Public Health

Country where clinical trial is conducted

Mongolia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be time to sputum culture conversion from positive to negative.		Eight weeks	No