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

This study is currently recruiting participants.
Verified December 2013 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: December 2, 2013
Last verified: December 2013

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
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

No publications provided

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: December 2, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Alcoholic
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Flaviviridae Infections
Ascorbic Acid
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Growth Substances processed this record on April 15, 2014