Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-13 @ 8:29 AM
Study NCT ID:
NCT06441734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-16
First Post:
2024-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Status in Autism Spectrum Disorders
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'iron status in autism spectrum disorders', 'timeFrame': '1 year', 'description': 'by cbc serum ferritin serum iron'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia, Iron Deficiency']}, 'referencesModule': {'references': [{'pmid': '33972922', 'type': 'RESULT', 'citation': 'Al-Beltagi M. Autism medical comorbidities. World J Clin Pediatr. 2021 May 9;10(3):15-28. doi: 10.5409/wjcp.v10.i3.15. eCollection 2021 May 9.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'to evaluate the prevalence of iron deficiency anemia in group with autism spectrum disorders in comparison to normal children group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children age from 2years to 12 years not having an infection or inflammatory conditions or physical illness', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children who are diagnosed with autism spectrum disorder according to DSM -V\n* not having infection inflammatory conditions chronic physical illness\n* children who are not receiving iron supplementation\n\nExclusion Criteria:\n\n* age below 2 years and above 12 years\n* having an infection or inflammatory conditions chronic physical illness\n* receiving iron supplementation'}, 'identificationModule': {'nctId': 'NCT06441734', 'briefTitle': 'Iron Status in Autism Spectrum Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Iron Status in Autism Spectrum Disorders in Children Attending Assiut Pediatric University Hospital', 'orgStudyIdInfo': {'id': 'anemia in autism'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'interventionNames': ['Diagnostic Test: cbc serum ferritin serum iron']}, {'label': 'control group', 'interventionNames': ['Diagnostic Test: cbc serum ferritin serum iron']}], 'interventions': [{'name': 'cbc serum ferritin serum iron', 'type': 'DIAGNOSTIC_TEST', 'description': 'by using sample of blood to do cbc and serum ferritin and serum iron during 1year', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'esraa hefzy shaker', 'role': 'CONTACT', 'email': 'esraahefzy31@gmail.com', 'phone': '01090930692'}, {'name': 'emad eldeen mahmoud hammad, professor', 'role': 'CONTACT', 'phone': '01223559943'}], 'overallOfficials': [{'name': 'khalaf abdelaal said, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'esraa hefzy shaker mostafa', 'investigatorAffiliation': 'Assiut University'}}}}