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

This study has been terminated.
Sponsor:
Information provided by:
Health Innovations, Frontier Research Institute
ClinicalTrials.gov Identifier:
NCT01250743
First received: November 29, 2010
Last updated: February 17, 2011
Last verified: November 2010
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250743

Locations
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
Investigators
Principal Investigator: Jeanne A Drisko, MD University of Kansas
Study Director: Michael A Catalano, MD Frontier Research Institute/Health Innovations
Study Chair: Terry A Grossman, MD Frontier Research Institute/Health Innovations
  More Information

Publications:
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
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
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 26, 2014