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

NCT ID: NCT01413360

Last Updated: 2016-07-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.

Conditions

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Chronic Hepatitis Chronic Hepatitis C Chronic Alcoholic Hepatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HD Vitamin C

High dose vitamin C

Group Type EXPERIMENTAL

High dose vitamin C

Intervention Type DRUG

Vitamin C, 3g per day (tid), with meal, per oral with water 100mL

Interventions

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High dose vitamin C

Vitamin C, 3g per day (tid), with meal, per oral with water 100mL

Intervention Type DRUG

Other Intervention Names

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Koreaeundan Vitamin C 1000

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Hwan Yoon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Hwan Yoon, M.D, Ph.D

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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VitC

Identifier Type: -

Identifier Source: org_study_id

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