Hepatitis C Clinical Trial
Official title:
Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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