Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-26 @ 2:21 PM
Study NCT ID:
NCT00408304
Status:
UNKNOWN
Last Update Posted:
2006-12-06
First Post:
2006-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2007-12'}, 'lastUpdateSubmitDate': '2006-12-05', 'studyFirstSubmitDate': '2006-12-05', 'studyFirstSubmitQcDate': '2006-12-05', 'lastUpdatePostDateStruct': {'date': '2006-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of omega three fatty acids would be estimated through two questionnaires which filled by the patients monthly'}, {'measure': 'with the BDI questionnaire which estimates the level of depression of the patient and'}, {'measure': "the SF36 questionnaire which provides information about the overall influence of a disease upon a patient's daily life and mental status."}], 'secondaryOutcomes': [{'measure': 'Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:'}, {'measure': 'albumin'}, {'measure': 'bilirubin'}, {'measure': 'ALT'}, {'measure': 'CRP'}, {'measure': 'hemoglobin'}, {'measure': 'WBC'}, {'measure': 'platelets'}]}, 'conditionsModule': {'keywords': ['interferon alpha', 'depression', 'omega 3'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic carriers of hepatitis C who start a course of interferon alpha treatment, and are treated in the liver clinic of Bnai Zion hospital.\n\nExclusion Criteria:\n\n* Disagreement to participation in trial.\n* Diagnosed and active mental illness.\n* Encephalopathic patients.\n* Patients with limited ability to understand the questionnaires or the informed consent process.'}, 'identificationModule': {'nctId': 'NCT00408304', 'briefTitle': 'Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': 'Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.', 'orgStudyIdInfo': {'id': 'Schiff1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'omega-3 fatty acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Elad Schiff', 'role': 'CONTACT', 'email': 'eschiff@email.arizona.edu', 'phone': '97248359281'}, {'name': 'Elad Schiff', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bnai Zion Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Elad Schiff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'affiliated with Bnai Zion MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}}}}