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

This study has been withdrawn prior to enrollment.
(Lack of study enrollment.)
Sponsor:
Collaborators:
Reliant Pharmaceuticals
Saint Luke's Health System Foundation
Information provided by (Responsible Party):
Truman Medical Center
ClinicalTrials.gov Identifier:
NCT00547716
First received: October 19, 2007
Last updated: September 13, 2013
Last verified: September 2013

October 19, 2007
September 13, 2013
June 2009
August 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00547716 on ClinicalTrials.gov Archive Site
To look at the effect of treatment of Hepatitis C on insulin resistance. [ Time Frame: While using Omega-3 Fatty Acid capsules ]
Same as current
Not Provided
Not Provided
 
Use of Omega-3 Fatty Acids (Fish Oil) in Patients With Chronic Hepatitis C Infection
The Effect of Omega-3 Fatty Acids (Omacor@) on the Response Rate to Antiviral Therapy in Patients With Chronic Hepatitis C Infection

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis C
  • Dietary Supplement: Omega-3 Fatty Acids
    Omega-3 Fatty Acids - 4 grams per day
    Other Name: Omacor@
  • Drug: Placebo comparator
  • Experimental: 1.
    Omega-3 Fatty Acids 4 grams/day
    Intervention: Dietary Supplement: Omega-3 Fatty Acids
  • Placebo Comparator: 2.
    Placebo comparator along with interferon.
    Intervention: Drug: Placebo comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00547716
07-48
No
Truman Medical Center
Truman Medical Center
  • Reliant Pharmaceuticals
  • Saint Luke's Health System Foundation
Principal Investigator: Laura M Alba, M.D. Truman Medical Center
Principal Investigator: Jagdish Nachnani, MD Truman Medical Center
Truman Medical Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP