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Completed

NCT Number: NCT01413360

The Effect of High Dose Vitamin C on the Liver Function 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-171, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

High dose vitamin C

Drug

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

Other names: Koreaeundan Vitamin C 1000

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Aug 10, 2011
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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