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

This study has been completed.
Sponsor:
Information provided by:
National Research Institute of Tuberculosis and Lung Disease, Iran
ClinicalTrials.gov Identifier:
NCT00564642
First received: November 27, 2007
Last updated: April 21, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention
Hepatitis
Tuberculosis
Drug: N Acetylcysteine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity

Resource links provided by NLM:


Further study details as provided by National Research Institute of Tuberculosis and Lung Disease, Iran:

Primary Outcome Measures:
  • Hepatotoxicity [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2007
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: N Acetylcysteine
    1200 mg, BD, 2weeks
    Other Name: ACC
  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564642

Locations
Iran, Islamic Republic of
National Research Institute of Tuberculosis and Lung Disease (NRITLD)
Tehran, Iran, Islamic Republic of, 19556
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dr. Baniasadi, National Research Institute of Tuberculosis and Lung Disease
ClinicalTrials.gov Identifier: NCT00564642     History of Changes
Other Study ID Numbers: 5344-21-07-86
Study First Received: November 27, 2007
Last Updated: April 21, 2009
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Acetylcysteine
Antitubercular Agents
N-monoacetylcystine
Anti-Bacterial Agents
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014