Use of Omega-3 Fatty Acids (Fish Oil) in Patients With Chronic Hepatitis C Infection
Primary Purpose
Hepatitis C
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty Acids
Placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Omega 3 fatty acids, Omacor, Interferon
Eligibility 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.
Sites / Locations
- Truman Medical Center
- Saint Luke's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1.
2.
Arm Description
Omega-3 Fatty Acids 4 grams/day
Placebo comparator along with interferon.
Outcomes
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.
Secondary Outcome Measures
To look at the effect of treatment of Hepatitis C on insulin resistance.
Full Information
NCT ID
NCT00547716
First Posted
October 19, 2007
Last Updated
January 5, 2017
Sponsor
University of Missouri, Kansas City
Collaborators
Reliant Pharmaceuticals, Saint Luke's Health System Foundation, Truman Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00547716
Brief Title
Use of Omega-3 Fatty Acids (Fish Oil) in Patients With Chronic Hepatitis C Infection
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 Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of study enrollment.
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Missouri, Kansas City
Collaborators
Reliant Pharmaceuticals, Saint Luke's Health System Foundation, Truman Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, Omega 3 fatty acids, Omacor, Interferon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1.
Arm Type
Experimental
Arm Description
Omega-3 Fatty Acids 4 grams/day
Arm Title
2.
Arm Type
Placebo Comparator
Arm Description
Placebo comparator along with interferon.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Fatty Acids
Other Intervention Name(s)
Omacor@
Intervention Description
Omega-3 Fatty Acids - 4 grams per day
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To look at the effect of treatment of Hepatitis C on insulin resistance.
Time Frame
While using Omega-3 Fatty Acid capsules
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura M Alba, M.D.
Organizational Affiliation
Truman Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jagdish Nachnani, MD
Organizational Affiliation
Truman Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.cdc.gov/Ncidod/diseases/hepatitis/c/index.htm
Description
Hepatitis information
Learn more about this trial
Use of Omega-3 Fatty Acids (Fish Oil) in Patients With Chronic Hepatitis C Infection
We'll reach out to this number within 24 hrs