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

This study has been completed.
Sponsor:
Information provided by:
Universidade do Sul de Santa Catarina
ClinicalTrials.gov Identifier:
NCT00983164
First received: September 22, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

September 22, 2009
September 22, 2009
January 2007
December 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Hepatitis C
  • Oxidative Stress
Dietary Supplement: Antioxidant Supplementation
antioxidant supplementation (vitamin E 800 mg, C 500 mg and zinc 40 mg) for 24 weeks
  • No Intervention: group I
    group I - controls
  • Experimental: group II
    group II - patients with hepatitis C without treatment
    Intervention: Dietary Supplement: Antioxidant Supplementation
  • Experimental: group III
    group III - patients with hepatitis C treated weekly with pegylated interferon combined with daily ribavirin
    Intervention: Dietary Supplement: Antioxidant Supplementation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2009
December 2007   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00983164
120/07 CEP, 120/07 CEP
No
Mirelle Sifroni Farias, Universidade Federal Santa Catarina
Universidade do Sul de Santa Catarina
Not Provided
Principal Investigator: Mirelle Sifroni Farias Universidade Federal Santa Catarina
Universidade do Sul de Santa Catarina
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP