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

Sponsor:	Truman Medical Center
Collaborators:	Reliant Pharmaceuticals Saint Luke's Health System Foundation
Information provided by:	Truman Medical Center
ClinicalTrials.gov Identifier:	NCT00547716

Purpose

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	Intervention
Hepatitis C	Dietary Supplement: Omega-3 Fatty Acids Drug: Placebo comparator

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Omega-3 Fatty Acids (Omacor@) on the Response Rate to Antiviral Therapy in Patients With Chronic Hepatitis C Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Omacor

U.S. FDA Resources

Further study details as provided by Truman Medical Center:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	200
Study Start Date:	June 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1.: Experimental Omega-3 Fatty Acids 4 grams/day	Dietary Supplement: Omega-3 Fatty Acids Omega-3 Fatty Acids - 4 grams per day
2.: Placebo Comparator Placebo comparator along with interferon.	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547716

Contacts

Contact: Laura Alba, M.D.	816-404-3995	lmalba@pol.net
Contact: Jagdish S. Nachnani, M.D.	816-404-1000	nachnanij@umkc.edu

Locations

United States, Missouri
Truman Medical Center	Recruiting
Kansas City, Missouri, United States, 64108
Principal Investigator: Laura M. Alba, M.D.
Principal Investigator: Jagdish S. Nachnani, M.D.
Saint Luke's Hospital	Recruiting
Kansas City, Missouri, United States, 64111
Principal Investigator: Laura Alba, M.D.

Sponsors and Collaborators

Truman Medical Center

Reliant Pharmaceuticals

Saint Luke's Health System Foundation

Investigators

Principal Investigator:	Laura M Alba, M.D.	Truman Medical Center
Principal Investigator:	Jagdish Nachnani, MD	Truman Medical Center

More Information

Additional Information:

Truman Medical Center This link exits the ClinicalTrials.gov site

Hepatitis information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Truman Medical Center ( Laura Alba, M.D. )
Study ID Numbers:	07-48
Study First Received:	October 19, 2007
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00547716 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Truman Medical Center:

Hepatitis C
Omega 3 fatty acids
Omacor
Interferon

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Flaviviridae Infections

Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Infection
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 09, 2009