Chronic Hepatitis CPhase 2NCT00408304
Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.
A Phase 2 study testing omega-3 fatty acid in people with Chronic Hepatitis C, run by Bnai Zion Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- omega-3 fatty acid
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2006to Dec 2007
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic carriers of hepatitis C who start a course of interferon alpha treatment, and are treated in the liver clinic of Bnai Zion hospital.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa
Elad Schiff, 97248359281, eschiff@email.arizona.edu
Elad Schiff
About this study
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.
Read the 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.
- Conditions
- Chronic Hepatitis C
- Being tested
- omega-3 fatty acid
- Keywords
- interferon alpha, depression, omega 3
- Medical subject headings
- Hepatitis C, Chronic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
hemoglobin
WBC
platelets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
- Study startDec 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Investigators
- Elad Schiff, MD, Principal investigator, affiliated with Bnai Zion MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408304
- Sponsor's protocol ID
- Schiff1
- Status last verified
- Dec 2006
- First submitted
- 5 Dec 2006
- Last updated
- 6 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.
- ClinicalTrials.gov ID
- NCT00408304
- Acronym / sponsor ID
- Schiff1
- Conditions
- Chronic Hepatitis C
- Keywords
- interferon alpha, depression, omega 3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Dec 2006
- Study completion
- Dec 2007
- First posted
- 6 Dec 2006 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic carriers of hepatitis C who start a course of interferon alpha treatment, and are treated in the liver clinic of Bnai Zion hospital.
Key exclusion criteria (4 listed)
- 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.
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 acid | Drug | – |
Primary outcome
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.
8 secondary outcomes
Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:
albumin
bilirubin
ALT
CRP
hemoglobin
WBC
platelets
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2006.
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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.
Elad Schiff, MD principal investigator
affiliated with Bnai Zion MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing omega-3 fatty acid in people with Chronic Hepatitis C, run by Bnai Zion Medical Center at 1 site in Israel.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of omega three fatty acids would be estimated through two questionnaires which filled by the patients monthly. The study lists 3 primary outcomes in all. 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 6 Dec 2006.