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A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients

NCT00366470 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2012-07-06

No results posted yet for this study

Summary

There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial. People receiving Vitamin D with anti TB therapy will be compared against people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery (as shown by a quicker sputum culture conversion).

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

A. 100,000 IU Cholecalciferol per dose of 3.3ml

100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months

OTHER

B. Migliol Oil without Cholecalciferol

3.3 ml Migliol Oil, every two weeks for two months

Sponsors & Collaborators

  • Dalhousie University

    collaborator OTHER

  • Peter Daley

    lead OTHER

Principal Investigators

  • Dilip Mathai, MD, FCAMS · Christian Medical College, Vellore, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00366470 on ClinicalTrials.gov