Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial (HepCAntSup)
Primary Purpose
Hepatitis C, Oxidative Stress
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Antioxidant Supplementation
Sponsored by
About this trial
This is an interventional supportive care trial for Hepatitis C focused on measuring antiviral therapy, antioxidant therapy, hepatitis C virus, oxidative stress, vitamin E
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.
Sites / Locations
- Hospital Nereu Ramos
- Hospital Universitário Universidade Federal Santa Catarina
- Policlínica II
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
group I
group II
group III
Arm Description
group I - controls
group II - patients with hepatitis C without treatment
group III - patients with hepatitis C treated weekly with pegylated interferon combined with daily ribavirin
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00983164
First Posted
September 22, 2009
Last Updated
September 22, 2009
Sponsor
Universidade do Sul de Santa Catarina
1. Study Identification
Unique Protocol Identification Number
NCT00983164
Brief Title
Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial
Acronym
HepCAntSup
Official Title
Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade do Sul de Santa Catarina
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Oxidative Stress
Keywords
antiviral therapy, antioxidant therapy, hepatitis C virus, oxidative stress, vitamin E
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group I
Arm Type
No Intervention
Arm Description
group I - controls
Arm Title
group II
Arm Type
Experimental
Arm Description
group II - patients with hepatitis C without treatment
Arm Title
group III
Arm Type
Experimental
Arm Description
group III - patients with hepatitis C treated weekly with pegylated interferon combined with daily ribavirin
Intervention Type
Dietary Supplement
Intervention Name(s)
Antioxidant Supplementation
Intervention Description
antioxidant supplementation (vitamin E 800 mg, C 500 mg and zinc 40 mg) for 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirelle Sifroni Farias
Organizational Affiliation
Universidade Federal Santa Catarina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Nereu Ramos
City
Florianópolis
State/Province
Santa Catarina
Country
Brazil
Facility Name
Hospital Universitário Universidade Federal Santa Catarina
City
Florianópolis
State/Province
Santa Catarina
Country
Brazil
Facility Name
Policlínica II
City
Florianópolis
State/Province
Santa Catarina
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial
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