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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
  Purpose

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.


Condition Intervention
Hepatitis C
Oxidative Stress
Dietary Supplement: Antioxidant Supplementation

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

Resource links provided by NLM:


Further study details as provided by Universidade do Sul de Santa Catarina:

Enrollment: 32
Study Start Date: January 2007
Study Completion Date: April 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: group I
group I - controls
Experimental: group II
group II - patients with hepatitis C without treatment
Dietary Supplement: Antioxidant Supplementation
antioxidant supplementation (vitamin E 800 mg, C 500 mg and zinc 40 mg) for 24 weeks
Experimental: group III
group III - patients with hepatitis C treated weekly with pegylated interferon combined with daily ribavirin
Dietary Supplement: Antioxidant Supplementation
antioxidant supplementation (vitamin E 800 mg, C 500 mg and zinc 40 mg) for 24 weeks

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983164

Locations
Brazil
Hospital Nereu Ramos
Florianópolis, Santa Catarina, Brazil
Hospital Universitário Universidade Federal Santa Catarina
Florianópolis, Santa Catarina, Brazil
Policlínica II
Florianópolis, Santa Catarina, Brazil
Sponsors and Collaborators
Universidade do Sul de Santa Catarina
Investigators
Principal Investigator: Mirelle Sifroni Farias Universidade Federal Santa Catarina
  More Information

No publications provided

Responsible Party: Mirelle Sifroni Farias, Universidade Federal Santa Catarina
ClinicalTrials.gov Identifier: NCT00983164     History of Changes
Other Study ID Numbers: 120/07 CEP, 120/07 CEP
Study First Received: September 22, 2009
Last Updated: September 22, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade do Sul de Santa Catarina:
antiviral therapy
antioxidant therapy
hepatitis C virus
oxidative stress
vitamin E

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 25, 2014