Use of Omega-3 Fatty Acids (Fish Oil) in Patients With Chronic Hepatitis C Infection

Hepatitis C Clinical Trial

Official title:

The Effect of Omega-3 Fatty Acids (Omacor@) on the Response Rate to Antiviral Therapy in Patients With Chronic Hepatitis C Infection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00547716
• Other study ID #: 07-48
• Status: Withdrawn
• Phase: N/A
• First received: October 19, 2007
• Last updated: January 5, 2017
• Start date: June 2009
• Est. completion date: August 2012

Study information

• Verified date: January 2017
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Dietary Supplement:
• Omega-3 Fatty Acids
Omega-3 Fatty Acids - 4 grams per day

Drug:
• Placebo comparator

Locations

Country	Name	City	State
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	Truman Medical Center	Kansas City	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
University of Missouri, Kansas City	Reliant Pharmaceuticals, Saint Luke's Health System Foundation, Truman Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess whether omega-3 fatty acids can improve early and sustained viral responses to treatment with interferon in patients with chronic infection.		To be determined by Hepatits C genotype
Secondary	To look at the effect of treatment of Hepatitis C on insulin resistance.		While using Omega-3 Fatty Acid capsules

External Links

•   Hepatitis information
•   Truman Medical Center