Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT03157050
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2017-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Iron May Increase Depression Among Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2017-05-16', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in patient health questionnaire-9 score', 'timeFrame': 'on day 0 of start of intravenous iron and 1 week after completion of intravenous iron', 'description': 'change in patient health questionnaire-9 score before and after intravenous iron therapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression', 'Hemodialysis Complication', 'Iron Deficiency Anemia']}, 'descriptionModule': {'briefSummary': 'the aim of this study is to assess whether increased ferritin after intravenous iron therapy will lead to increased prevalence of major depression among treated patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hemodialysis patients with iron deficiency anemia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age was above 19 years,\n2. patient on maintenance hemodialysis,\n3. patient had iron deficiency anemia (ferritin \\> 100 ng/ml)\n\nExclusion Criteria:\n\n1. patient has history of depression or already using antidepressant medication,\n2. Lack of ferritin level increase ≥ 50% from baseline level before IV iron administration,\n3. patient already on oral or intravenous iron supplement'}, 'identificationModule': {'nctId': 'NCT03157050', 'briefTitle': 'Intravenous Iron May Increase Depression Among Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Intravenous Iron May Increase Depression Among Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'BN-13058'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intravenous iron therapy', 'type': 'OTHER', 'description': 'each patient with iron def anemia received an IV syringe of iron sucrose 100 mg every dialysis session for 10 doses'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mahmoud Hamada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'collaborators': [{'name': 'New Jeddah Clinic Hospital', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Internal Medicine - Faculty of Medicine', 'investigatorFullName': 'Mahmoud Hamada imam', 'investigatorAffiliation': 'Benha University'}}}}