NCT00547716

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
1.6 years until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

3.2 years

First QC Date

October 19, 2007

Last Update Submit

January 5, 2017

Conditions

Hepatitis C

Keywords

Hepatitis COmega 3 fatty acidsOmacorInterferon

Outcome Measures

Primary Outcomes (1)

  • To assess whether omega-3 fatty acids can improve early and sustained viral responses to treatment with interferon in patients with chronic infection.

    To be determined by Hepatits C genotype

Secondary Outcomes (1)

  • To look at the effect of treatment of Hepatitis C on insulin resistance.

    While using Omega-3 Fatty Acid capsules

Study Arms (2)

1.

EXPERIMENTAL

Omega-3 Fatty Acids 4 grams/day

Dietary Supplement: Omega-3 Fatty Acids

2.

PLACEBO COMPARATOR

Placebo comparator along with interferon.

Drug: Placebo comparator

Interventions

Omega-3 Fatty AcidsDIETARY_SUPPLEMENT

Omega-3 Fatty Acids - 4 grams per day

Also known as: Omacor@
1.
Placebo comparatorDRUG
2.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients \> 18 years of age
  • Patients with chronic hepatitis C infection
  • Patients receiving interferon for treatment of hepatitis C

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

Fatty Acids, Omega-3Omacor

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Laura M Alba, M.D.

    Truman Medical Center

    PRINCIPAL INVESTIGATOR

  • Jagdish Nachnani, MD

    Truman Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2007

First Posted

October 23, 2007

Study Start

June 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 9, 2017

Record last verified: 2017-01

Locations

US(2)