Use of Omega-3 Fatty Acids (Fish Oil) in Patients With Chronic Hepatitis C Infection
Information source: Truman Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C
Intervention: Omega-3 Fatty Acids (Dietary Supplement); Placebo comparator (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Truman Medical Center Official(s) and/or principal investigator(s):
Laura M Alba, M.D., Principal Investigator, Affiliation: Truman Medical Center
Overall contact:
Laura Alba, M.D., Phone: 816-404-3995, Email: lmalba@pol.net
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.
Clinical Details
Official title: The Effect of Omega-3 Fatty Acids (Omacor@) on the Response Rate to Antiviral Therapy in Patients With Chronic Hepatitis C Infection
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To assess whether omega-3 fatty acids can improve early and sustained viral responses to treatment with interferon in patients with chronic infection.
Secondary outcome: To look at the effect of treatment of Hepatitis C on insulin resistance.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Laura Alba, M.D., Phone: 816-404-3995, Email: lmalba@pol.net
Truman Medical Center, Kansas City, Missouri 64108, United States; Recruiting
Laura M. Alba, M.D., Principal Investigator
Jagdish S. Nachnani, M.D., Principal Investigator
Saint Luke's Hospital, Kansas City, Missouri 64111, United States; Recruiting
Jagdish S Nachnani, M.D., Principal Investigator
Additional Information
Truman Medical Center Hepatitis information
Starting date: August 2008
Ending date: January 2011
Last updated: August 14, 2008
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