Clinical trial NCT00983164: Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial
Official title: Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Oxidative Stress
Keywords: antiviral therapy
antioxidant therapy
hepatitis C virus
oxidative stress
vitamin E
Lead sponsor: Universidade do Sul de Santa Catarina
Sponsor class: OTHER_GOV
First posted: 2009-09-23
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Hospital Nereu Ramos
state: Santa Catarina
city: Florianópolis
country: Brazil
facility: Hospital Universitário Universidade Federal Santa Catarina
state: Santa Catarina
city: Florianópolis
country: Brazil
facility: Policlínica II
state: Santa Catarina
Study officials:
affiliation: Universidade Federal Santa Catarina
name: Mirelle Sifroni Farias
role: PRINCIPAL_INVESTIGATOR
References: