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

This study has been terminated.
Information provided by:
Health Innovations, Frontier Research Institute
ClinicalTrials.gov Identifier:
First received: November 29, 2010
Last updated: February 17, 2011
Last verified: November 2010

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 Intervention
Hepatitis C
Dietary Supplement: ascorbic acid (vitamin C)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Health Innovations, Frontier Research Institute:

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

Secondary Outcome Measures:
  • anti-viral efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measured by reduction of circulating hepatitis C viral levels

  • aspartate aminotransferase (AST or SGOT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    reduced circulating levels of AST (or SGOT), as a measure of liver inflammation

  • alanine aminotransferase (ALT or SGPT) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    reduced circulating levels of ALT (or SGPT), as a measure of liver inflammation

Estimated Enrollment: 10
Study Start Date: January 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: November 29, 2010
Last Updated: February 17, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 08, 2015