Blood Antioxidant Status in Chronic Hepatitis C Patients Before and After Antioxidant Supplementation: a Randomized Clinical Trial
HepCAntSup
1 other identifier
interventional
32
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2007
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 22, 2009
CompletedFirst Posted
Study publicly available on registry
September 23, 2009
CompletedSeptember 23, 2009
September 1, 2009
11 months
September 22, 2009
September 22, 2009
Conditions
Keywords
Study Arms (3)
group I
NO INTERVENTIONgroup I - controls
group II
EXPERIMENTALgroup II - patients with hepatitis C without treatment
group III
EXPERIMENTALgroup III - patients with hepatitis C treated weekly with pegylated interferon combined with daily ribavirin
Interventions
antioxidant supplementation (vitamin E 800 mg, C 500 mg and zinc 40 mg) for 24 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital Nereu Ramos
Florianópolis, Santa Catarina, Brazil
Hospital Universitário Universidade Federal Santa Catarina
Florianópolis, Santa Catarina, Brazil
Policlínica II
Florianópolis, Santa Catarina, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mirelle Sifroni Farias
Universidade Federal Santa Catarina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 22, 2009
First Posted
September 23, 2009
Study Start
January 1, 2007
Primary Completion
December 1, 2007
Study Completion
April 1, 2009
Last Updated
September 23, 2009
Record last verified: 2009-09