The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients

Phase 4

Completed

• Conditions: Chronic Hepatitis; Chronic Hepatitis C; Chronic Alcoholic Hepatitis
• Interventions: Drug: High dose vitamin C

• Registration Number: NCT01413360
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Results First Submitted: 2015-05-20
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-06
• Last Update Submitted: 2016-06-06
• Results First Posted: 2016-07-15
• Last Update Posted: 2016-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. 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

2. 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HD Vitamin C	High dose vitamin C	High dose vitamin C

Primary Outcome Measures

Name	Time	Method
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks	Baseline and 12 weeks	Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level

Secondary Outcome Measures

Name	Time	Method
The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks	Baseline and 12 weeks	Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of