Back to resultsThe Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
Primary Purpose
Chronic Hepatitis, Chronic Hepatitis C, Chronic Alcoholic Hepatitis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High dose vitamin C
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis
Eligibility Criteria
Inclusion Criteria:
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 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HD Vitamin C
Arm Description
High dose vitamin C
Outcomes
Primary Outcome Measures
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level
Secondary Outcome Measures
The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks
Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level
Full Information
NCT ID
NCT01413360
First Posted
August 9, 2011
Last Updated
June 6, 2016
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01413360
Brief Title
The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
Official Title
Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis, Chronic Hepatitis C, Chronic Alcoholic Hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HD Vitamin C
Arm Type
Experimental
Arm Description
High dose vitamin C
Intervention Type
Drug
Intervention Name(s)
High dose vitamin C
Other Intervention Name(s)
Koreaeundan Vitamin C 1000
Intervention Description
Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
Primary Outcome Measure Information:
Title
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
Description
Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks
Description
Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Hwan Yoon, M.D, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-171
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
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