NCT00408304

Brief Summary

The purpose of the study is to check whether development of depression as a side effect of interferon alpha treatment in chronic carriers of hepatitis C can be prevented by omega-3 fatty acids.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 6, 2006

Status Verified

December 1, 2006

First QC Date

December 5, 2006

Last Update Submit

December 5, 2006

Conditions

Chronic Hepatitis C

Keywords

interferon alphadepressionomega 3

Outcome Measures

Primary Outcomes (3)

  • The effect of omega three fatty acids would be estimated through two questionnaires which filled by the patients monthly

  • with the BDI questionnaire which estimates the level of depression of the patient and

  • the SF36 questionnaire which provides information about the overall influence of a disease upon a patient's daily life and mental status.

Secondary Outcomes (8)

  • Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:

  • albumin

  • bilirubin

  • ALT

  • CRP

  • +3 more secondary outcomes

Interventions

omega-3 fatty acidDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic carriers of hepatitis C who start a course of interferon alpha treatment, and are treated in the liver clinic of Bnai Zion hospital.

You may not qualify if:

  • Disagreement to participation in trial.
  • Diagnosed and active mental illness.
  • Encephalopathic patients.
  • Patients with limited ability to understand the questionnaires or the informed consent process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Hepatitis C, ChronicDepression

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Elad Schiff, MD

    affiliated with Bnai Zion MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 5, 2006

First Posted

December 6, 2006

Study Start

December 1, 2006

Study Completion

December 1, 2007

Last Updated

December 6, 2006

Record last verified: 2006-12

Locations

IL(1)