Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT03456258
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2018-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001772', 'term': 'Blood Cell Count'}], 'ancestors': [{'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-28', 'studyFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2018-02-28', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemoglobin level', 'timeFrame': '2 months', 'description': 'Measure hemoglobin level two months after treatment'}], 'secondaryOutcomes': [{'measure': 'Serum ferritin', 'timeFrame': '2 months', 'description': 'Measure serum ferritin level'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia of Pregnancy']}, 'descriptionModule': {'briefSummary': 'The study aims to compare the efficacy and the safety of Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy.', 'detailedDescription': 'The study was done at ainshams university maternity hospital on 100 pregnant women randomized in two groups .\n\nGroup one lactoferrin group Group two ferrous sulphate group'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women from 20 to 40 years\n* iron deficiency anemia (mild and moderate)\n* gestational age 13 to 26 weeks\n* singleton viable pregnancy.\n\nExclusion Criteria:\n\n* history of anemia due to chronic blood loss\n* hemolytic anemia\n* severe anemia\n* history of peptic ulcer'}, 'identificationModule': {'nctId': 'NCT03456258', 'acronym': 'Lactoferrin', 'briefTitle': 'Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy,a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Ainshams maternity hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactoferrin', 'description': 'To measure hemoglobin difference and serum ferritin', 'interventionNames': ['Diagnostic Test: Complete blood count']}, {'type': 'EXPERIMENTAL', 'label': 'Ferrous sulphate', 'description': 'To measure hemoglobin difference and serum ferritin', 'interventionNames': ['Diagnostic Test: Complete blood count']}], 'interventions': [{'name': 'Complete blood count', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Serum ferritin'], 'description': 'To measure hemoglobin difference and serum ferritin levels .', 'armGroupLabels': ['Ferrous sulphate', 'Lactoferrin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'state': 'Abbasia', 'country': 'Egypt', 'facility': 'Ainshams maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed M Ragab, MBBCH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ainshams university maternity hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ahmed Ragab', 'investigatorAffiliation': 'Ain Shams University'}}}}