- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00547716
Use of Omega-3 Fatty Acids (Fish Oil) in Patients With Chronic Hepatitis C Infection
The Effect of Omega-3 Fatty Acids (Omacor@) on the Response Rate to Antiviral Therapy in Patients With Chronic Hepatitis C Infection
Hepatitis C virus infection is the most common blood-borne infection in the United States and is a leading cause of chronic liver disease affecting 130 million people around the world. It is estimated that 1.6% of the US population may be affected by Hepatitis C infection. The only recommended treatment that has been approved for your condition is the use of interferon and ribavirin. In patients with chronic Hepatitis C, there tends to be an accumulation of fat in the liver. Fatty liver has been associated with failure of treatment.
The accumulation of fat in the liver has been blamed on a particular type of fat called triglycerides. Fish oil, by reducing a type of fat called VLDL, can lower the triglyceride concentration by as much as 50 percent or more. This study seeks to determine if the administration of fish oil along with standard treatment to patients with Hepatitis C will increase the treatment response rates.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hepatic steatosis may be present in up to 66% of cases of chronic Hepatitis C infection. Previous studies have reported steatosis to be an independent predictor of treatment failure in patients with chronic hepatitis C infection.
The pathogenesis of hepatic steatosis in chronic Hepatitis C infection has not been fully elucidated. Hepatic steatosis is a manifestation of excessive triglyceride accumulation in the liver. Hypertriglyceridemia may benefit from Omega-3 fatty acid (fish oil supplements) which, by reducing VLDL production can lower the serum triglyceride concentration by as much as 50 percent or more.
The treatment of chronic hepatitis C results in an average sustained viral response rate of 54%-63%. We have found response rates of around 50% on treatment of patients. We hypothesize that by giving omega-3 fatty acids along with interferon therapy for patients with Hepatitis C, we may be able to increase the treatment response rates. Thus, the purpose of the study is to look at the effect of omega 3 fatty acids on early and sustained viral response rates in patients with chronic HCV infection.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
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Kansas City, Missouri, United States, 64108
- Truman Medical Center
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Kansas City, Missouri, United States, 64111
- Saint Luke's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients > 18 years of age
- Patients with chronic hepatitis C infection
- Patients receiving interferon for treatment of hepatitis C
Exclusion Criteria:
- pregnant or lactating patients
- End stage target organ damage in diabetes mellitus: advanced renal failure (serum creatinine >2.0 mg/dl) with or without dialysis, severe neuropathy, advanced peripheral vascular disease.
- Anticipated life expectancy less than 2 years
- Co-existent etiologies for liver disease
- Alcohol consumption more than 30 g per day in men and more than 20 g per day in women.
- Patients on Omega-3 fatty acid supplementation or those patients who report eating oily fish such as salmon, albacore tuna, sardines, etc. twice a week or more frequently.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1.
Omega-3 Fatty Acids 4 grams/day
|
Omega-3 Fatty Acids - 4 grams per day
Other Names:
|
Placebo Comparator: 2.
Placebo comparator along with interferon.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess whether omega-3 fatty acids can improve early and sustained viral responses to treatment with interferon in patients with chronic infection.
Time Frame: To be determined by Hepatits C genotype
|
To be determined by Hepatits C genotype
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To look at the effect of treatment of Hepatitis C on insulin resistance.
Time Frame: While using Omega-3 Fatty Acid capsules
|
While using Omega-3 Fatty Acid capsules
|
Collaborators and Investigators
Investigators
- Principal Investigator: Laura M Alba, M.D., Truman Medical Center
- Principal Investigator: Jagdish Nachnani, MD, Truman Medical Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
Other Study ID Numbers
- 07-48
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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