Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT06989060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-25
First Post:
2025-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional Status in Children With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline', 'description': 'Body weight of children with Down syndrome will be measured in kilograms using a calibrated scale by trained personnel.'}, {'measure': 'Height', 'timeFrame': 'Baseline', 'description': 'Height of children with Down syndrome will be measured in centimeters using a calibrated stadiometer by trained personnel.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Baseline', 'description': 'BMI will be calculated using the formula: weight (kg) divided by height in meters squared (m²). Nutritional status will be classified based on WHO Child Growth Standards (underweight, normal weight, overweight, etc.).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Down Syndrome']}, 'descriptionModule': {'briefSummary': "To evaluate the nutritional status of children with Down's syndrome and to determine the prevalence of nutritional deficiencies among those children.\n\nTo discuss factors associated with their nutritional status, such as dietary habits and comorbid health conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children diagnosed with Down's syndrome Age between 2- 5 years of both sexes", 'eligibilityCriteria': "Inclusion Criteria:\n\nClinical diagnosis of children with Down's syndrome Age between 2- 5 years of both sexes\n\nExclusion Criteria:\n\nChildren diagnosed with any other chronic illness or any other medical problem"}, 'identificationModule': {'nctId': 'NCT06989060', 'acronym': 'DS', 'briefTitle': 'Nutritional Status in Children With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Nutritional Status and Detection of Nutritional Deficiencies in Children With Down Syndrome', 'orgStudyIdInfo': {'id': 'nutritional status in DS'}}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university child hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Esraa G Gomaa, master degree', 'role': 'CONTACT', 'email': 'esraag63@gmail.com', 'phone': '+2001069932021'}, {'name': 'Osama M Asheer, professor', 'role': 'CONTACT', 'email': 'asheer1970@aun.edu.eg', 'phone': '+2001001348864'}], 'overallOfficials': [{'name': 'Osama M Asheer, professor of pediatrics', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assiut university child hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Esraa Gamal Gomaa', 'investigatorAffiliation': 'Assiut University'}}}}