Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-28 @ 3:03 PM
Study NCT ID:
NCT06335368
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2022-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Nutritional and Growth Status in Rett Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015518', 'term': 'Rett Syndrome'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}], 'ancestors': [{'id': 'D038901', 'term': 'X-Linked Intellectual Disability'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gender, age , disease history checklist', 'timeFrame': '1 year'}, {'measure': 'Change in Body height', 'timeFrame': '1 year', 'description': 'The growth status of the case will be assessed'}, {'measure': 'Change in Body weight', 'timeFrame': '1 year', 'description': 'The growth status of the case will be assessed'}, {'measure': 'Change in knee height', 'timeFrame': '1 year', 'description': 'The growth status of the case will be assessed'}, {'measure': 'Change in arms height', 'timeFrame': '1 year', 'description': 'The growth status of the case will be assessed and growth curve'}, {'measure': 'Change in waist', 'timeFrame': '1 year', 'description': 'The growth status of the case will be assessed'}, {'measure': 'Change in hip circumferences', 'timeFrame': '1 year', 'description': 'The growth status of the case will be assessed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rett Syndrome', 'Neurologic Disorder']}, 'descriptionModule': {'briefSummary': "Children with Rett syndrome are in a period of rapid growth, and proper and appropriate nutritional support is very important. Past foreign research papers it has been pointed out that most of these patients have feeding difficulties, dysphagia, and digestive tract abnormalities, are often constipated, and may suffer from osteoporosis and other problems. Lack of proper nutritional support will seriously affect their growth, development and health. in view of There is a lack of relevant research in China, so the investigators would like to use this research to explore the nutritional, growth and postural status of Rett's disease patients, as the reference direction and goal of dietary adjustment and nutritional support for patients, and establish dietary and nutritional strategies for sick children in Taiwan."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Rett syndrome patient.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rett syndrome patient.\n\nExclusion Criteria:\n\n* Not Rett syndrome patient.'}, 'identificationModule': {'nctId': 'NCT06335368', 'briefTitle': 'Assessment of Nutritional and Growth Status in Rett Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Assessment of Nutritional and Growth Status in Rett Syndrome Patients', 'orgStudyIdInfo': {'id': '201512178RINC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nutrition and Growth Status', 'type': 'OTHER', 'description': 'Nutrition and Growth Status'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Assessment of nutritional and growth status in Rett syndrome patient'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}