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

NCT00564642 | Completed DMC

• 1 other identifier: 5344-21-07-86
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Hepatotoxicity

  Two weeks

Interventions

N Acetylcysteine DRUG

1200 mg, BD, 2weeks

Also known as: ACC

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Research Institute of Tuberculosis and Lung Disease, Iran: lead

Study Sites (1)

National Research Institute of Tuberculosis and Lung Disease (NRITLD)

Tehran, 19556, Iran

Location

MeSH Terms

Conditions

Hepatitis; Tuberculosis

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Shadi Baniasadi, PhD

  National Research Institute of Tuberculosis and Lung Disease (NRITLD)-Shaheed Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 28, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 22, 2009

Record last verified: 2009-04

Locations

IR (1)