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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Seoul National University Hospital
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital Identifier:
First received: August 9, 2011
Last updated: November 26, 2014
Last verified: November 2014
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.

Condition Intervention Phase
Chronic Hepatitis
Chronic Hepatitis C
Chronic Alcoholic Hepatitis
Drug: High dose vitamin C
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The change of serum alanine aminotransferase level [ Time Frame: after 12 weeks ] [ Designated as safety issue: Yes ]
    Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration - Baseline serum ALT level

Secondary Outcome Measures:
  • The change of serum interleukin 22 level [ Time Frame: after 12 weeks ] [ Designated as safety issue: Yes ]
    Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration - Baseline IL-22 level

Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HD Vitamin C
High dose vitamin C
Drug: High dose vitamin C
Vitamin C, 3g per day (tid), with meal, per oral with water 100mL

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.

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01413360

Contact: Jung-Hwan Yoon, M.D, Ph.D +82-2072-2228
Contact: Eun Sun Jang, M.D. +82-2072-2228

Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-171
Contact: Jung-Hwan Yoon, M.D, Ph.D    +82-2072-2228   
Sponsors and Collaborators
Seoul National University Hospital
Study Director: Jung-Hwan Yoon, M.D, Ph.D Seoul National University Hospital
  More Information

Responsible Party: Jung-Hwan Yoon, Professor, Seoul National University Hospital Identifier: NCT01413360     History of Changes
Other Study ID Numbers: VitC 
Study First Received: August 9, 2011
Last Updated: November 26, 2014
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis A
Hepatitis C, Chronic
Hepatitis, Chronic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Liver Diseases, Alcoholic
Picornaviridae Infections
RNA Virus Infections
Substance-Related Disorders
Virus Diseases
Ascorbic Acid
Growth Substances
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents processed this record on May 26, 2016