|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 19, 2007 | ||||||||
| Last Updated Date | June 5, 2009 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00547716 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
To look at the effect of treatment of Hepatitis C on insulin resistance. [ Time Frame: While using Omega-3 Fatty Acid capsules ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Use of Omega-3 Fatty Acids (Fish Oil) in Patients With Chronic Hepatitis C Infection | ||||||||
| Official Title ICMJE | The Effect of Omega-3 Fatty Acids (Omacor@) on the Response Rate to Antiviral Therapy in Patients With Chronic Hepatitis C Infection | ||||||||
| 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. |
||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Hepatitis C | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arms / Comparison Groups |
|
||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | January 2011 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00547716 | ||||||||
| Responsible Party | Laura Alba, M.D., Truman Medical Center | ||||||||
| Study ID Numbers ICMJE | 07-48 | ||||||||
| Study Sponsor ICMJE | Truman Medical Center | ||||||||
| Collaborators ICMJE |
|
||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Truman Medical Center | ||||||||
| Verification Date | June 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||