Hepatitis CNCT00547716
Use of Omega-3 Fatty Acids (Fish Oil) in Patients With Chronic Hepatitis C Infection
A study testing Omega-3 Fatty Acids in people with Hepatitis C, run by University of Missouri, Kansas City at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Omega-3 Fatty Acids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients > 18 years of age
- Patients with chronic hepatitis C infection
- Patients receiving interferon for treatment of hepatitis C
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Truman Medical Center
Kansas City, Missouri, 64108
Saint Luke's Hospital
Kansas City, Missouri, 64111
About this 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
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Omega-3 Fatty Acids, Placebo comparator
- Keywords
- Hepatitis C, Omega 3 fatty acids, Omacor, Interferon
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidsDietary supplement
Also called Omacor@
Omega-3 Fatty Acids - 4 grams per day
Placebo comparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| 1. | Experimental | Omega-3 Fatty Acids 4 grams/day Receives: Dietary Supplement: Omega-3 Fatty Acids |
| 2. | Placebo comparator | Placebo comparator along with interferon. Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether omega-3 fatty acids can improve early and sustained viral responses to treatment with interferon in patients with chronic infection.
Measured: To be determined by Hepatits C genotype
Secondary outcomes (1)
To look at the effect of treatment of Hepatitis C on insulin resistance.
Measured: While using Omega-3 Fatty Acid capsules
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startJun 2009
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Lack of study enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Reliant Pharmaceuticals, Saint Luke's Health System Foundation, Truman Medical Center
- Responsible party
- Sponsor
- Investigators
- Laura M Alba, M.D., Principal investigator, Truman Medical CenterJagdish Nachnani, MD, Principal investigator, Truman Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547716
- Sponsor's protocol ID
- 07-48
- Status last verified
- Jan 2017
- First submitted
- 19 Oct 2007
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega-3 Fatty Acids (Omacor@) on the Response Rate to Antiviral Therapy in Patients With Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT00547716
- Acronym / sponsor ID
- 07-48
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, Omega 3 fatty acids, Omacor, Interferon
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of study enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- Reliant Pharmaceuticals, Saint Luke's Health System Foundation, Truman Medical Center
- Study start
- Jun 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. | Experimental | Dietary Supplement: Omega-3 Fatty AcidsOmega-3 Fatty Acids 4 grams/day |
| 2. | Placebo comparator | Drug: Placebo comparatorPlacebo comparator along with interferon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients > 18 years of age
- Patients with chronic hepatitis C infection
- Patients receiving interferon for treatment of hepatitis C
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty AcidsAlso: Omacor@Omega-3 Fatty Acids - 4 grams per day | Dietary supplement | 1. |
| Placebo comparator | Drug | 2. |
Primary outcome
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
1 secondary outcome
To look at the effect of treatment of Hepatitis C on insulin resistance.
Time frame: While using Omega-3 Fatty Acid capsules
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura M Alba, M.D. principal investigator
Truman Medical Center
Jagdish Nachnani, MD principal investigator
Truman Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acids in people with Hepatitis C, run by University of Missouri, Kansas City at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.