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

NCT01413360 | Completed Phase 4 Results

• 1 other identifier: VitC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis; Chronic Hepatitis C; Chronic Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

• The Change in Serum Alanine Aminotransferase Level From Baseline to 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 Outcomes (1)

• The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks

  Baseline and 12 weeks

Study Arms (1)

HD Vitamin C

EXPERIMENTAL

High dose vitamin C

Drug: High dose vitamin C

Interventions

High dose vitamin C DRUG

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

Also known as: Koreaeundan Vitamin C 1000

HD Vitamin C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-171, South Korea

Location

MeSH Terms

Conditions

Hepatitis, Chronic; Hepatitis C, Chronic; Hepatitis, Alcoholic

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Jung-Hwan Yoon
• Organization: Seoul National University Hospital

yoonjh@snu.ac.kr

+82-2-2072-2228

Study Officials

• Jung-Hwan Yoon, M.D, Ph.D

  Seoul National University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 10, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: July 15, 2016
• Results First Posted: July 15, 2016

Record last verified: 2016-06

Locations

KR (1)