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Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.

Primary Purpose

Chronic Hepatitis C

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
omega-3 fatty acid
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Hepatitis C focused on measuring interferon alpha, depression, omega 3

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Bnai Zion Medical CenterRecruiting

Outcomes

Primary Outcome Measures

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 Outcome Measures

Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:
albumin
bilirubin
ALT
CRP
hemoglobin
WBC
platelets

Full Information

First Posted
December 5, 2006
Last Updated
December 5, 2006
Sponsor
Bnai Zion Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00408304
Brief Title
Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.
Official Title
Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bnai Zion Medical Center

4. Oversight

5. Study Description

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.
Detailed Description
Omega-3 fatty acids are known as an alternative treatment for different conditions, including mental conditions, such as depression. We assume that combining omega-3 with the treatment by interferon alpha may prevent the development of depression, which is quite a common side effect of the interferon alpha.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
interferon alpha, depression, omega 3

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
omega-3 fatty acid
Primary Outcome Measure Information:
Title
The effect of omega three fatty acids would be estimated through two questionnaires which filled by the patients monthly
Title
with the BDI questionnaire which estimates the level of depression of the patient and
Title
the SF36 questionnaire which provides information about the overall influence of a disease upon a patient's daily life and mental status.
Secondary Outcome Measure Information:
Title
Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:
Title
albumin
Title
bilirubin
Title
ALT
Title
CRP
Title
hemoglobin
Title
WBC
Title
platelets

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic carriers of hepatitis C who start a course of interferon alpha treatment, and are treated in the liver clinic of Bnai Zion hospital. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elad Schiff, MD
Organizational Affiliation
affiliated with Bnai Zion MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elad Schiff
Phone
97248359281
Email
eschiff@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
Elad Schiff

12. IPD Sharing Statement

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Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.

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