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Efficacy of Oral Zinc Administration as an Adjunct Therapy in New Pulmonary Tuberculosis (Category I) Patients

NCT00698386 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2009-09-15

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the efficacy of oral Zinc administration in new smear positive pulmonary tuberculosis patients. Evidence is available suggesting that zinc deficiency rapidly diminishes antibody- and cell-mediated immune responses in both humans and animals and renders the individual susceptible to a variety of pathogens. This micronutrient has also been found to be useful in the treatment of lung tuberculosis in limited number of patients.

We are conducting this study in category-I patients (As per World Health Organization, Geneva classification of tuberculosis) having lung tuberculosis to see the efficacy and also to see any change in the immunological parameters.

Conditions

  • Pulmonary Tuberculosis

Interventions

DIETARY_SUPPLEMENT

Zinc supplement

Zinc miconutrient supplements have been prepared by Cadila pharmaceutical Ltd., India, in the form of capsules.Each micronutrient capsule contains 50mg zinc (as zinc sulphate) in a lactose matrix.In this clinical trial one tablet of zinc as oral supplement will be given everyday during the entire course in line with the directly observed treatment, short-course (DOTS) strategy recommended by the World Health Organization.

DIETARY_SUPPLEMENT

Placebo

Placebo have been prepared by Cadila pharmaceutical Ltd., India, in the form of capsules.The placebo consisted of lactose alone. Supplement and placebo capsules were indistinguishable in appearance both externally and internally.

Sponsors & Collaborators

  • Ministry of Science and Technology, India

    lead OTHER_GOV

Principal Investigators

  • Surendra Kumar Sharma · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-09-30
Completion
2009-09-30

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 NCT00698386 on ClinicalTrials.gov