Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-26 @ 11:46 AM
Study NCT ID:
NCT03830034
Status:
UNKNOWN
Last Update Posted:
2019-02-05
First Post:
2019-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031621', 'term': 'ferrous fumarate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-02', 'studyFirstSubmitDate': '2019-02-02', 'studyFirstSubmitQcDate': '2019-02-02', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobine (Hb) Rise', 'timeFrame': 'after 12 weeks of treatment.', 'description': 'follow up CBC after 12 weeks of treatment given'}], 'secondaryOutcomes': [{'measure': 'Hemoglobine (Hb) Rise', 'timeFrame': 'after 4,8 weeks of treatment.', 'description': 'Follow up CBC after 4,8 weeks of treatment given'}, {'measure': 'Adverse effects of the medication given', 'timeFrame': '3months', 'description': 'constipation, nausea, allergy.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia']}, 'descriptionModule': {'briefSummary': "Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).", 'detailedDescription': "Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat)."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'this trial conducted on treatment of iron deficiency anemia in pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women at 14 -18 weeks of gestation calculated from the first day of their last menstrual period and confirmed or modified by ultrasound\n* Hemoglobin level 8-10.5 g/dL\n* Serum ferritin\\<15µg/L\n\nExclusion Criteria:\n\n* The presence of anemia from causes other than iron deficiency(e.g: Folat deficiency anemia,Vitamin B12 deficiency, ect…).\n* Multiple gestations\n* The presence of clinical and/or laboratory evidence of hepatic, renal, hematological or cardiovascular disease\n* Patients with known gastritis\n* History of mal-absorption syndrome\n* Those with known hypersensitivity to iron preparations\n* Those under current iron supplementation'}, 'identificationModule': {'nctId': 'NCT03830034', 'briefTitle': 'Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IDA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amino Acid chelated iron tab 15 mg group', 'description': 'Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) prepared by egyptian pharmaceutical company (nerhadou) once daily (a dose recommended by the company of the product).', 'interventionNames': ['Drug: Amino Acid chelated iron tab 15 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group', 'description': 'Contain 75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb\\<9g/dl) this dose can be doubled as recommended by the company of the product.', 'interventionNames': ['Drug: Ferrous Fumarate tab 350 mg( 115 mg elemental iron)']}], 'interventions': [{'name': 'Amino Acid chelated iron tab 15 mg', 'type': 'DRUG', 'otherNames': ['Ferrotron'], 'description': 'Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) a dose recommended by the company of the product.\n\nIron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.\n\nSubstances that inhibit absorption such as tannins \\& milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.\n\nFollow up will be done for all the pregnant women included in our studies at baseline \\& then 4, 8 \\& 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.', 'armGroupLabels': ['Amino Acid chelated iron tab 15 mg group']}, {'name': 'Ferrous Fumarate tab 350 mg( 115 mg elemental iron)', 'type': 'DRUG', 'otherNames': ['Haemacaps'], 'description': '75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb\\<9g/dl) this dose can be doubled as recommended by the company of the product.\n\nSome instructions will be given to all the pregnant women included in our study as follow: Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.\n\nSubstances that inhibit absorption such as tannins \\& milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.\n\nFollow up will be done for all the pregnant women included in our studies at baseline \\& then 4, 8 \\& 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed.', 'armGroupLabels': ['Ferrous Fumarate tab 350 mg( 115 mg elemental iron) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25187', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed A Elshahawy, MD', 'role': 'CONTACT', 'email': 'ahmedshafy@hotmail.com', 'phone': '+201223266380'}], 'facility': 'Ain shams university maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Elshahawy, MD', 'role': 'CONTACT', 'email': 'ahmedshafy@hotmail.com', 'phone': '+01223266380'}], 'overallOfficials': [{'name': 'Ahmed Elshahawy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Ahmed Abdel Shafy El Shahawy', 'investigatorAffiliation': 'Ain Shams University'}}}}