Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial

Hepatitis C Clinical Trial

— HepCAntSup  

Official title:

Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983164
• Other study ID #: 120/07 CEP
• Secondary ID: 120/07 CEP
• Status: Completed
• Phase: N/A
• First received: September 22, 2009
• Last updated: September 22, 2009
• Start date: January 2007
• Est. completion date: April 2009

Study information

• Verified date: September 2009
• Source: Universidade do Sul de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The objective of the present study is to evaluate the antioxidant status in the blood of HCV patients treated with pegylated interferon (2a 1.5 ug/kg; 2b 180 ug) combined with ribavirin (1000 to 1250 mg) before and after supplementation of vitamins E, C and the mineral zinc (800 mg,500 mg and 40 mg; respectively) during six months.

Description:

The WHO estimated that around 170 million people are infected by HCV, about 3% of the world population. HCV is the leading cause of acute hepatitis and chronic liver disease, which may lead to cirrhosis and hepatocellular carcinoma.

The combined therapy with interferon with or without pegylation associated with ribavirin has shown greater sustained virological response than monotherapy with interferon-alpha, however this response still represents around 60% of cases. The mechanisms by which HCV causes cellular damage are not yet well understood, however immune liver damage, direct cytotoxic damage mediated by different viral products and also oxidative stress have been implicated in the pathogenesis of chronic hepatitis C. Several studies support that reactive oxygen species (ROS) and oxidative stress are involved in the pathogenesis of hepatitis C, despite that increased ROS levels in HCV patients might be beneficial by suppressing HCV replication. ROS are involved in several diseases and cause oxidative damage to lipids, DNA, proteins and carbohydrates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• without the presence of illnesses associated with systemic diseases, no chronic alcoholism, without HIV coinfection, and were not participating in other studies.

• Patients with hepatitis C were selected according to the Clinical Protocol and Guidelines for Therapeutic Hepatitis C Viral.

• Group I - All subjects were negative for HCV, HBV, HIV, HBsAg, anti-HBc total, anti-HCV and normal serum transaminases.

Exclusion Criteria:

• Patients with one of the following laboratory abnormalities were also excluded:

leukocytes, neutrophils, platelets, serum creatinine 1.5 times upper limit of normal, elevated thyroid stimulating hormone, alpha-fetoprotein above normal limits, and/or focal lesion on ultrasound performed within 1 month of study entry.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Oxidative Stress

Intervention

Dietary Supplement:
• Antioxidant Supplementation
antioxidant supplementation (vitamin E 800 mg, C 500 mg and zinc 40 mg) for 24 weeks

Locations

Country	Name	City	State
Brazil	Hospital Nereu Ramos	Florianópolis	Santa Catarina
Brazil	Hospital Universitário Universidade Federal Santa Catarina	Florianópolis	Santa Catarina
Brazil	Policlínica II	Florianópolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Sul de Santa Catarina

Country where clinical trial is conducted

Brazil,