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

June 6, 2016 updated by: Jung-Hwan Yoon, Seoul National University Hospital

Phase 4 Study of High Dose Vitamin C in Chronic Hepatitis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-171
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Koreaeundan Vitamin C 1000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks
Time Frame: Baseline and 12 weeks
Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks
Time Frame: Baseline and 12 weeks
Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Jung-Hwan Yoon, M.D, Ph.D, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (Estimate)

August 10, 2011

Study Record Updates

Last Update Posted (Estimate)

July 15, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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