Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT06252103
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2024-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C011819', 'term': 'ferrous gluconate'}, {'id': 'D007781', 'term': 'Lactoferrin'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061250', 'term': 'Transferrins'}, {'id': 'D033862', 'term': 'Iron-Binding Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007782', 'term': 'Lactoglobulins'}, {'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D008667', 'term': 'Metalloproteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Total 40 females from 14 to 35 weeks of pregnancy with Hemoglobin level between 8.5 to 10.5 gm/dl, recruited from the obstetric inpatient/outpatient clinic at Ain Shams University, Maternity hospital.\n\nThis study included two groups:\n\nGroup I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.\n\nGroup II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.\n\nhematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-02-07', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Hemoglobin (Hb) level', 'timeFrame': '4 weeks', 'description': 'hemoglobin will be measured before and after treatment by 4 weeks (HB in gm/dl)'}, {'measure': 'serum ferritin', 'timeFrame': '4 weeks', 'description': 'serum ferritin will be measured before and after treatment by 4 weeks (ferritin in ug/l )'}], 'secondaryOutcomes': [{'measure': 'gastrointestinal side effects', 'timeFrame': '4 weeks', 'description': '(nausea , vomiting , constipation ) will be assessed before and after treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iron deficiency anemia during pregnancy', 'ferrous gluconate', 'lactoferrin'], 'conditions': ['Lactoferrin With Ferrous Gluconate More Superior Than Ferrous Gluconate Alone in Treatment of Iron Deficiency Anemia']}, 'descriptionModule': {'briefSummary': "Study Procedures:\n\nAll patients will undergo the following:\n\nInformed consent will be obtained from all the participants in this study before enrolling in this study and all participants will be subjected to a detailed clinical assessment including: a detailed history, general, abdominal examinations, Investigations.\n\n1. History taking:\n\n * Personal history: name, age, occupation and address.\n * Menstrual and obstetric history: Date of LMP, expected date of delivery which will be calculated according to Naegle's rule and gestational age. In addition to history of presence of any menstrual irregularities, duration.\n * Past History: of Anemia in previous pregnancy, other diseases like Thalassemia, sickle cell anemia, liver or renal diseases or any other condition that may affect hemoglobin.\n2. Medical examination:\n\n * General: Assessment of complexion and vital data (blood pressure, pulse, capillary refill)\n * Abdominal examination to assess fundal height.\n3. Investigations to perform will include:\n\nLaboratory: Complete blood count (microcytic hypochromic anemia) Imaging: Ultrasound to assess biometry to exclude fetal growth restriction. Women will be divided in two groups with 20 in each group, the first group will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks and the second group will receive lactoferrin sachets 100mg with ferrous gluconate 300mg twice per day for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.\n\nWomen will be told to record side effects as nausea, vomiting, abdominal discomfort and constipation.\n\nWomen will have a blood sample (CBC) withdrawn after 2 to 4 weeks to assess rise in pregnant anemia.", 'detailedDescription': 'This study included two groups:\n\nGroup I: 20 patients were given ferrous gluconate 300 mg (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.\n\nGroup II: 20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.\n\nhematological parameters (rise in hemoglobin) and the adverse effects of both drugs were studied at registration and after 4 weeks'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': '* The study will include women with the following inclusion and exclusion criteria:\n\nInclusion criteria:\n\n1. Pregnant women with single fetus\n2. Microcytic hypochromic anemia, mild anemia Hb 10 to 10.5 g/dl) and moderate anemia (Hb 7 to 9.9 g/dl)\n3. Gestational age (14 - 35 weeks)\n4. Serum ferritin level \\<24 ng/dl\n\nExclusion Criteria:\n\n1. Associated chronic medical disorder (CKD, liver disease, peptic ulcer and chronic blood loss).\n2. Associated bleeding disorder\n3. Anaemia requiring blood tranfusion (Hb \\< 7gm/dL)\n4. Hypersensitivity to iron preparations\n5. Haemoglobinopathies (G6PD, thalassemias, sickle cell disease)'}, 'identificationModule': {'nctId': 'NCT06252103', 'briefTitle': 'Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Lactoferrin With Ferrous Gluconate Versus Ferrous Gluconate in Treatment of Iron Deficiency Anemia During Pregnancy', 'orgStudyIdInfo': {'id': 'FMASU MS298/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group I', 'description': 'the first group 20 patients will receive one tab of ferrous gluconate 300mg administered orally twice per day for 4 weeks (Ferrous-Gluconate®, tab.300mg glucofer, Egypt) two times daily.', 'interventionNames': ['Drug: Ferrous Gluconate 300 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group II', 'description': '20 patients were given lactoferrin 100mg (Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily for 4 weeks Patients were assigned to take the medication orally; once daily before breakfast, and Pravotin (100 sachets were be dissolved each in ¼ glass of water and taken before breakfast). Patients were advised to avoid the intake of tea, coffee, milk, milk products, antacids and calcium preparation within 2 hours before or after iron capsules.', 'interventionNames': ['Drug: ferrous gluconate with lactoferrin']}], 'interventions': [{'name': 'Ferrous Gluconate 300 MG', 'type': 'DRUG', 'otherNames': ['(Ferrous-Gluconate®, tab.300mg glucofer, Egypt'], 'description': 'iron salt one tab 300 mg contain 35 mg of elemental iron given 2 doses 600 mg per day', 'armGroupLabels': ['group I']}, {'name': 'ferrous gluconate with lactoferrin', 'type': 'DRUG', 'otherNames': ['Pravotin-sachets®,100mg, Hygint, Egypt) with ferrous gluconate twice daily.'], 'description': 'Lactoferrin is a glycoprotein from the transferrin family consist of 691 amino acids,Lactoferrin is a protein found in cow milk and human milk', 'armGroupLabels': ['group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6825344', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain shams university maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'AMR Saad, doctoral', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of medicine Ain shams university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}