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A Pilot Study of High-Dose, Intravenous Ascorbic Acid (Vitamin C) to Treat Hepatitis C

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ClinicalTrials.gov Identifier: NCT01250743
Recruitment Status : Terminated
First Posted : December 1, 2010
Last Update Posted : February 18, 2011
Information provided by:
Health Innovations, Frontier Research Institute

Brief Summary:
The purpose of this pilot study is to learn whether high doses of ascorbic acid (vitamin c), given intravenously to patients with chronic hepatitis due to infection with the genotype 1 version of the hepatitis C virus, are safe, well-tolerated and able to reduce the amount of virus circulating in the patients' blood.

Condition or disease Intervention/treatment
Hepatitis C Dietary Supplement: ascorbic acid (vitamin C)

Detailed Description:

Hepatitis C virus (HCV) chronically infects 1% to 3% of the world's population, including about 3.9 million infected patients in the United States, with an estimated 36,000 new cases in the US each year. 70-85% of infected individuals develop a chronic infection complicated by chronic liver disease during the next 20 to 30 years, which is the tenth leading cause of death in the US. HCV is implicated in the development of hepato-cellular carcinoma. Chronic HCV hepatitis is the most frequent reason for liver transplantation. HCV genotype 1 is the most common genetic variant of HCV causing HCV hepatitis in the US. It responds less well to conventional anti-HCV treatment than the other HCV genotypes, so that 60% of genotype 1 patients fail conventional therapy due to the virus's resistance to treatment and/or due to toxic side effects of the therapy.

Extracellular levels of ascorbic acid (vitamin c) attainable only by high-dose, intravenous administration, are reported to have in vitro and in vivo anti-cancer and anti-viral effects in humans and animals. Ascorbic acid briefly generates extracellular hydrogen peroxide, an oxidative stress specifically toxic to cancer cells and cells infected with viruses, including HCV, but not to normal cells. High-dose, intravenous ascorbic acid has been given to large numbers of patients, particularly cancer patients, with anecdotal reports of good safety and occasional benefit. Given the foregoing, the investigators propose that there is sufficient rationale for a careful pilot study of the safety and anti-viral efficacy of infused ascorbic acid in HCV genotype 1 hepatitis.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Study of the Safety, Tolerability and Anti-Viral Activity of High Dose Intravenous Ascorbic Acid in Patients Chronically Infected With Hepatitis C Virus Genotype 1, Who Have Failed Prior Therapy With Interferon-alpha and Ribavirin
Study Start Date : January 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ascorbic Acid (Vitamin C) Dietary Supplement: ascorbic acid (vitamin C)
intravenous vitamin C, 25 to 100 grams, once or twice a week, for five months
Other Name: Vitamin C

Primary Outcome Measures :
  1. number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]
    clinical and/or laboratory adverse events

Secondary Outcome Measures :
  1. anti-viral efficacy [ Time Frame: 6 months ]
    measured by reduction of circulating hepatitis C viral levels

  2. aspartate aminotransferase (AST or SGOT) [ Time Frame: 6 months ]
    reduced circulating levels of AST (or SGOT), as a measure of liver inflammation

  3. alanine aminotransferase (ALT or SGPT) [ Time Frame: 6 months ]
    reduced circulating levels of ALT (or SGPT), as a measure of liver inflammation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • hepatitis C, genotype 1
  • failed treatment with interferon-alpha and ribavirin
  • abstain from alcohol consumption for the duration of the study

Exclusion Criteria:

  • cirrhosis
  • decompensated liver disease
  • glucose6phosphate dehydrogenase deficiency
  • AST or ALT more than 5 times upper limit of normal
  • platelets less than 125,000
  • diabetes mellitus
  • alcohol and/or drug abuse within 1 year of screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250743

United States, Kansas
University of Kansas Medical Center, Department of Integrative Medicine
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Health Innovations, Frontier Research Institute
Principal Investigator: Jeanne A Drisko, MD University of Kansas Medical Center
Study Director: Michael A Catalano, MD Frontier Research Institute/Health Innovations
Study Chair: Terry A Grossman, MD Frontier Research Institute/Health Innovations

Responsible Party: Michael A Catalano MD, Research Director, Health Innovations, Frontier Research Institute
ClinicalTrials.gov Identifier: NCT01250743     History of Changes
Other Study ID Numbers: FRI-101
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: November 2010

Keywords provided by Health Innovations, Frontier Research Institute:
genotype 1

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents