NCT00983164

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Universidade do Sul de Santa Catarina · Other Government
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hepatitis C
• Oxidative Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Antioxidant Supplementation	antioxidant supplementation (vitamin E 800 mg, C 500 mg and zinc 40 mg) for 24 weeks

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-12-01
• Completion: 2009-04-01
• First posted: 2009-09-23
• Last updated: 2009-09-23

Locations

3 sites across 1 country: Brazil