Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-28 @ 5:11 AM
Study NCT ID:
NCT05529550
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2022-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Nutritional Status and Role of Insulin-like Growth Factor-1 in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013789', 'term': 'Thalassemia'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-02', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IGF-1', 'timeFrame': 'at the time of recruitment', 'description': 'insulin-like growth factor-1 which measured by enzyme linked immunosorbent assay (ELISA).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insulin-like growth factor 1'], 'conditions': ['Thalassemia']}, 'descriptionModule': {'briefSummary': 'Many studies done on children with thalassemia have shown a variable prevalence of defective IGF-I concentrations have been shown to be low in the majority of children, with or without GH deficiency. The Aim of this study to assess nutritional status and role of Insulin-like growth factor 1 (IGF-1) and its associating factors in children with thalassemia major'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '67 Children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia, and 35 healthy control', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia major.\n\nExclusion Criteria:\n\n* Children with other chronic diseases (cardiac, renal, vascular)\n* Children with malignancy'}, 'identificationModule': {'nctId': 'NCT05529550', 'briefTitle': 'Assessment of Nutritional Status and Role of Insulin-like Growth Factor-1 in Children', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Assessment of Nutritional Status and Role of Insulin-like Growth Factor-1 in Children With Thalassemia Major', 'orgStudyIdInfo': {'id': 'insulin-like growth factor-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': '67 children in the age group of 2-18 years with confirmed diagnosis of Beta thalassemia major.'}, {'label': 'Healthy control', 'description': '35 healthy children'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shibīn al Kawm', 'country': 'Egypt', 'facility': 'Samar Abd El-Hameed', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Samar Abdelhameed', 'investigatorAffiliation': 'Menoufia University'}}}}