Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital Identifier:
First received: August 9, 2011
Last updated: June 6, 2016
Last verified: June 2016
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 in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level

Enrollment: 10
Study Start Date: August 2011
Study Completion Date: December 2014
Primary Completion Date: December 2013 (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
Other Name: Koreaeundan Vitamin C 1000

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   (Adult, Senior)
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

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-171
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
Results First Received: May 20, 2015
Last Updated: June 6, 2016
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents processed this record on October 21, 2016