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

September 14, 2009 updated by: Ministry of Science and Technology, India

Efficacy of Oral Zinc Administration as an Adjunct Therapy in Category I Pulmonary Tuberculosis Along With Assessment of Immunological Parameters (Double-blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Malnutrition is commonly observed in patients with pulmonary tuberculosis. There are reports claiming patients with active pulmonary tuberculosis are malnourished as indicated by diminished visceral proteins, anthropometric indexes, and micronutrient status. Zinc plays role in protecting cells from the damaging effects of free radicals. Zinc supplementation was shown to prevent pulmonary pathology due to hypoxia-induced lung damage in rats. The role of zinc in faster sputum smear conversion has not yet been studied. However, there are reports which confirms, in vitro cellular killing of tubercle bacilli by macrophages after zinc supplementation.

We are investigating oral zinc supplement for its efficacy in TB patients in a "double-blind placebo-controlled randomized clinical trial" fashion. We are conducting this trial in Category-I pulmonary TB Patients (as per RNTCP, Ministry of Health and Family Welfare, Govt.of India), and are assessing the outcome in the form of clinical improvement, sputum conversion and immunological parameters. This is a multi-centric trial sponsored by the Department of Biotechnology, Ministry of Science and Technology, Govt. of India.

Supplements and placebo have been prepared by Cadila pharmaceutical Ltd., India, in the form of tablets. Each micronutrient tablet contains 50mg zinc (as zinc sulphate) in a lactose matrix. The placebo consisted of lactose alone. Supplement and placebo capsules were indistinguishable in appearance both externally and internally. 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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
      • New Delhi, India, 110029
        • Recruiting
        • All India Institute of Medcial Sciences-
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alladi Mohan, MD
        • Sub-Investigator:
          • Depender K Mitra, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly diagnosed sputum smear positive pulmonary TB cases.

Exclusion Criteria:

  • Hypersensitivity to Category I anti-TB drugs.
  • Category II pulmonary TB and multi-drug resistant TB (MDR-TB). patients.
  • Presence of secondary immunodeficiency states: HIV, organ transplantation, diabetes mellitus, malignancy, treatment with corticosteroids Hepatitis B and C positivity.
  • Patients with extrapulmonary TB and/or patients requiring surgical intervention.
  • Currently receiving cytotoxic therapy, or have received it within the last 3 months.
  • Pregnancy and lactation.
  • Patients with a known seizure disorder.
  • Patients with known symptomatic cardiac diseases, such as arrhythmias or coronary artery disease.
  • Patients with abnormal renal function (serum creatinine more than 2 mg/dl or more than 2+ proteinuria or both).
  • Patients with abnormal hepatic functions (serum bilirubin > 1.5 mg/dl; AST, ALT, SAP more than 1.5 times of upper limit of normal; PT = 1.3 times of control).
  • Patients with hematological abnormalities (WBC lesser than or equal to3000/ cubic mm; platelets less than or equal to 100,000/cubic mm).
  • Seriously ill and moribund patients with complications: low lung reserve, marked tachypnoea, chronic corpulmonale, congestive cardiac failure, BMI<15, severe hypoalbuminemia.
  • Patients unable to survive for less than 6 months.
  • Patients unable to comply with the treatment regimen.
  • Patients with history of alcohol or drug abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time of sputum conversion as well as the early sputum conversion from the baseline between the two groups will be evaluated.
Time Frame: 6 months
6 months
The cure rate will be evaluated as the primary parameter of efficacy.
Time Frame: 6 months
6 months
The relapse at an interval of 6,12,18 and 24 months after the completion of the therapy in patients of category-I pulmonary TB will be compared in both the groups.
Time Frame: 30 months
30 months
Recording of any clinical adverse reactions at anytime during the study for assessment of safety.
Time Frame: 30 months
30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
An additional secondary efficacy endpoint is the patient's and physician's global assessment of the clinical cure.
Time Frame: 30 months
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Science and Technology, India

Investigators

  • Principal Investigator: Surendra Kumar Sharma, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ANTICIPATED)

September 1, 2009

Study Completion (ANTICIPATED)

September 1, 2009

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (ESTIMATE)

June 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DTPR7885/Med/141166/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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