Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity

April 21, 2009 updated by: National Research Institute of Tuberculosis and Lung Disease, Iran
Tuberculosis is one of the major health problems in developing countries. Isoniazid, rifampin and pyrazinamide, the first line drugs used for tuberculosis chemotherapy, are associated with hepatotoxicity. The rate of hepatotoxicity has been reported to be much higher in developing countries compared to that in advanced countries with a similar dose schedule. Oxidative stress has proposed as one of the mechanisms responsible for anti-tuberculosis drugs induced hepatic injury. The oxidative stress is closely associated with decrease of glutathione levels. In the present study N acetylcysteine, a precursor of glutathione, was investigated for hepatoprotective effect against anti-tuberculosis drugs induced liver injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 19556
        • National Research Institute of Tuberculosis and Lung Disease (NRITLD)

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

60 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Two sputum specimens positives for tubercle bacilli on direct smear microscopy
  • No previous anti-TB chemotherapy higher than two weeks
  • Aged 60 years and over
  • Agreement to participate in the study

Exclusion Criteria:

  • Alcohol consumption
  • Viral disease (Hepatitis,...)
  • Abnormal pretreatment LFT level
  • Chronic disease (liver and kidney disease, asthma,...)
  • Additional hepatotoxic drug use
  • HIV positive
  • Liver TB
  • Patient in a moribund state
  • Hemoptysis

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hepatotoxicity
Time Frame: Two weeks
Two weeks

Collaborators and Investigators

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

Sponsor

National Research Institute of Tuberculosis and Lung Disease, Iran

Investigators

  • Principal Investigator: Shadi Baniasadi, PhD, National Research Institute of Tuberculosis and Lung Disease (NRITLD)-Shaheed Beheshti University of Medical Sciences

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

November 1, 2007

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 27, 2007

First Posted (ESTIMATE)

November 28, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2009

Last Update Submitted That Met QC Criteria

April 21, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5344-21-07-86

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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