Status:
COMPLETED
The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
Lead Sponsor:
Seoul National University Hospital
Conditions:
Chronic Hepatitis
Chronic Hepatitis C
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.
Detailed Description
The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.
Eligibility Criteria
Inclusion
- Chronic hepatitis C patients
- positive anti-HCV antibody more than 6 months
- serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
- not indicated for antiviral therapy with interferon and ribavirin
- Chronic alcoholic hepatitis
- significant alcohol drinking history and no other cause of chronic hepatitis
- serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
Exclusion
- Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or alcoholic hepatitis
- decompensated liver cirrhosis
- platelet \< 50,000/uL or white blood cell \< 1,500/uL
- need and willing for antiviral therapy
- significant renal dysfunction (GFR \< 30 mL/min/kg) or history of renal stone
- hepatotonic drug (i.e. silymarin, garlic oil, aronamin gold) usage within 2 weeks
- pregnancy, lactating woman
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01413360
Start Date
August 1 2011
End Date
December 1 2014
Last Update
July 15 2016
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-171