Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT04584905
Status:
UNKNOWN
Last Update Posted:
2021-06-03
First Post:
2020-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional Assessment of Children With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015362', 'term': 'Child Nutrition Disorders'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-31', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-10-10', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of nutritional status of children with CKD.', 'timeFrame': 'from January 2021 to June 2021', 'description': 'by measuring body mass index in kg/m2.'}], 'secondaryOutcomes': [{'measure': 'Assess STAMP screening tool', 'timeFrame': 'from January 2021 to June 2021', 'description': 'Five steps STAMP assessment for detection of malnutrition in children with CKD.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic kidney disease'], 'conditions': ['Nutrition Disorders, Child']}, 'descriptionModule': {'briefSummary': 'Primary outcome is assessment of nutritional status of children with CKD. Secondary outcome is assessment STAMP screening tool for detection of malnutrition of CKD children.', 'detailedDescription': 'Pediatric Chronic Kidney Disease (CKD) has systemic implication on all aspects of normal development, including nutrition, growth, bone and mineral metabolism and neurocognitive function .\n\nChronic Kidney Disease (CKD) introduces a unique set of nutritional challenges for the growing and developing child .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children of both sexes. Diagnosed as chronic kidney disease. Age: 2 years up to 15 Years Children', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children of both sexes.\n* Diagnosed as chronic kidney disease.\n* Age: 2 years up to 15 Years Children.\n\nExclusion Criteria:\n\n* • Age: less than 2 years old child and more than 15 years old child.\n\n * Previously diagnosed to have any co- morbid or systemic disease other than CKD.\n * Irregular dialysis.\n * Renal transplant.'}, 'identificationModule': {'nctId': 'NCT04584905', 'briefTitle': 'Nutritional Assessment of Children With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Nutritional Assessment of Children With Chronic Kidney Disease Attending Assuit University Children Hospital', 'orgStudyIdInfo': {'id': 'nutrition in CKD'}}, 'armsInterventionsModule': {'interventions': [{'name': 'dietary supplements for CKD patients', 'type': 'DIETARY_SUPPLEMENT', 'description': 'follow up and assessment of nutritional status of CKD patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'maram M amir, resident', 'role': 'CONTACT', 'email': 'maramamir1994@yahoo.com', 'phone': '01014808876'}], 'facility': 'Assiut Universty Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'maram mohamed amir, resident doctor', 'role': 'CONTACT', 'email': 'Maramamior1994@yahoo.com', 'phone': '01014808876'}, {'name': 'mohamed A AbdelMoez, prof', 'role': 'CONTACT', 'email': 'abdellatefabdelmoez@yahoo.com', 'phone': '01005208016'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Maram Mohamed Amir Fathy', 'investigatorAffiliation': 'Assiut University'}}}}