Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-30 @ 5:17 AM
Study NCT ID:
NCT04101461
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2019-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007501', 'term': 'Iron'}, {'id': 'D001772', 'term': 'Blood Cell Count'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2019-09-22', 'studyFirstSubmitQcDate': '2019-09-22', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of anemic women at time of delivery', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'The mean level of maternal Hemoglobin at 37-38 weeks .', 'timeFrame': '6 months'}, {'measure': "The incidence of patients' reported side effect", 'timeFrame': '6 months'}, {'measure': 'The difference in serum ferritin', 'timeFrame': '6 months'}, {'measure': 'The difference in serum hepcidin', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia of Pregnancy']}, 'descriptionModule': {'briefSummary': 'Anemia is known as a condition in which the hemoglobin level is lower than normal. Anemia is one of the most common complications during pregnancy. Anemia in pregnancy is defined as a hemoglobin level \\< 110 g/L . Anemia is an important risk factor in pregnancy which leads to both maternal and fetal morbidity and mortality.\n\nThe pregnant woman needs more iron during pregnancy, so iron deficiency anemia is very common during pregnancy. In Egypt; iron deficiency anemia affects about one in every two pregnant women, especially in rural areas. Pregnant women require about 27 mg/day elemental iron to cover their increased need. The pregnant women should start taking a daily supplement of 30mg of elemental iron as a preventive measure against iron deficiency anemia especially in poor countries.\n\nObesity is defined as having an excessive amount of body fat. The body mass index, a measurement based on height and weight, determines the obese if the figure more than 30 kg/m2. There is an increased rate of overweight and obesity among pregnant women. According to the World Health Organization, 46% of adult females in Egypt are obese.\n\nMany researches in the literature revealed a strong relationship between high BMI in pregnancy and iron deficiency anemia. Hepcidin is an iron regulating hormone in the body. Increases in iron levels in the plasma stimulate the production of hepcidin, which blocks iron absorption from the diet, so; hepcidin production is suppressed in the case of iron deficiency.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant woman in a singleton pregnancy (12-14 weeks).\n2. BMI (30- 40 kg/m2).\n3. Normal hemoglobin level (\\>11 g/dL).\n4. Normal hematocrit (Hct 31-41%).\n5. Normal ferritin level (6-130 ng/mL).\n6. Women willingness to participate in the study.\n7. Women living in the nearby area to make follow-up visits possible.\n\nExclusion Criteria:\n\n1. Multiple gestations.\n2. Women received a recent blood transfusion.\n3. Women with threatened miscarriage.\n4. Women are known to have pathological blood loss.\n5. Intolerant to oral iron form.\n6. History of the hematologic disorder.\n7. Women used iron in the past 3 months.\n8. Women with chronic diseases (hypertension, diabetes, renal diseases, thyroid disease……).'}, 'identificationModule': {'nctId': 'NCT04101461', 'briefTitle': 'The Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Effectiveness of Single Versus Double Daily Dose of Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant Women', 'orgStudyIdInfo': {'id': 'IDA-Obese'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I: 27 mg elemental iron', 'description': 'will receive PharaFerro27; Devart Lab Company, Egypt; once daily starting at 12 -14 weeks until 37-38 weeks', 'interventionNames': ['Drug: Iron', 'Diagnostic Test: Complete blood count', 'Diagnostic Test: Serum ferritin', 'Diagnostic Test: Serum hepcidin', 'Diagnostic Test: Serum Iron', 'Diagnostic Test: Serum total iron binding capacity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II: 54 mg elemental iron', 'description': 'will receive two tablets of PharaFerro27; Devart Lab Company, Egypt; daily starting at 12 -14 weeks until 37-38 weeks', 'interventionNames': ['Drug: Iron', 'Diagnostic Test: Complete blood count', 'Diagnostic Test: Serum ferritin', 'Diagnostic Test: Serum hepcidin', 'Diagnostic Test: Serum Iron', 'Diagnostic Test: Serum total iron binding capacity']}], 'interventions': [{'name': 'Iron', 'type': 'DRUG', 'description': 'PharaFerro27; Devart Lab Company, Egypt', 'armGroupLabels': ['Group I: 27 mg elemental iron', 'Group II: 54 mg elemental iron']}, {'name': 'Complete blood count', 'type': 'DIAGNOSTIC_TEST', 'description': 'to assess the anemia', 'armGroupLabels': ['Group I: 27 mg elemental iron', 'Group II: 54 mg elemental iron']}, {'name': 'Serum ferritin', 'type': 'DIAGNOSTIC_TEST', 'description': 'to assess the anemia', 'armGroupLabels': ['Group I: 27 mg elemental iron', 'Group II: 54 mg elemental iron']}, {'name': 'Serum hepcidin', 'type': 'DIAGNOSTIC_TEST', 'description': 'to assess the iron abosrption', 'armGroupLabels': ['Group I: 27 mg elemental iron', 'Group II: 54 mg elemental iron']}, {'name': 'Serum Iron', 'type': 'DIAGNOSTIC_TEST', 'description': 'to assess the anemia', 'armGroupLabels': ['Group I: 27 mg elemental iron', 'Group II: 54 mg elemental iron']}, {'name': 'Serum total iron binding capacity', 'type': 'DIAGNOSTIC_TEST', 'description': 'to assess the anemia', 'armGroupLabels': ['Group I: 27 mg elemental iron', 'Group II: 54 mg elemental iron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': "Woman's Health Hospital - Assiut university", 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Mohammed Khairy Ali', 'investigatorAffiliation': 'Assiut University'}}}}