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

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01413360
First received: August 9, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 2013
Estimated 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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01413360

Contacts
Contact: Jung-Hwan Yoon, M.D, Ph.D +82-2072-2228 yoonjh@snu.ac.kr
Contact: Eun Sun Jang, M.D. +82-2072-2228 jeses19@gmail.com

Locations
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     yoonjh@snu.ac.kr    
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT01413360     History of Changes
Other Study ID Numbers: VitC
Study First Received: August 9, 2011
Last Updated: April 22, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Alcoholic
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
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
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013