A Pilot Study of High-Dose, Intravenous Ascorbic Acid (Vitamin C) to Treat Hepatitis C
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| ClinicalTrials.gov Identifier: NCT01250743 |
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Recruitment Status :
Terminated
First Posted : December 1, 2010
Last Update Posted : February 18, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C | Dietary Supplement: ascorbic acid (vitamin C) | Not Applicable |
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 |
| 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 |
- number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 months ]clinical and/or laboratory adverse events
- anti-viral efficacy [ Time Frame: 6 months ]measured by reduction of circulating hepatitis C viral levels
- aspartate aminotransferase (AST or SGOT) [ Time Frame: 6 months ]reduced circulating levels of AST (or SGOT), as a measure of liver inflammation
- alanine aminotransferase (ALT or SGPT) [ Time Frame: 6 months ]reduced circulating levels of ALT (or SGPT), as a measure of liver inflammation
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older 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
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 | |
| 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 |
| Other Study ID Numbers: |
FRI-101 |
| First Posted: | December 1, 2010 Key Record Dates |
| Last Update Posted: | February 18, 2011 |
| Last Verified: | November 2010 |
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genotype 1 |
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Hepatitis A Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Vitamins Ascorbic Acid Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |