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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00547716
Recruitment Status : Withdrawn (Lack of study enrollment.)
First Posted : October 23, 2007
Last Update Posted : January 9, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Hepatitis C Dietary Supplement: Omega-3 Fatty Acids Drug: Placebo comparator

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2009
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1.
Omega-3 Fatty Acids 4 grams/day
Dietary Supplement: Omega-3 Fatty Acids
Omega-3 Fatty Acids - 4 grams per day
Other Name: Omacor@
Placebo Comparator: 2.
Placebo comparator along with interferon.
Drug: Placebo comparator

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To look at the effect of treatment of Hepatitis C on insulin resistance. [ Time Frame: While using Omega-3 Fatty Acid capsules ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

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): NCT00547716

United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
University of Missouri, Kansas City
Reliant Pharmaceuticals
Saint Luke's Health System Foundation
Truman Medical Center
Principal Investigator: Laura M Alba, M.D. Truman Medical Center
Principal Investigator: Jagdish Nachnani, MD Truman Medical Center
More Information

Additional Information:
Responsible Party: University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT00547716     History of Changes
Other Study ID Numbers: 07-48
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by University of Missouri, Kansas City:
Hepatitis C
Omega 3 fatty acids

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections