Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-02 @ 6:20 AM
Study NCT ID:
NCT04844957
Status:
UNKNOWN
Last Update Posted:
2022-04-05
First Post:
2021-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope Child and it 's RAAS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2021-03-28', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'OI symptom scores', 'timeFrame': '3 months after taking the drug', 'description': 'OI symptom scores after vitamin D supplementation'}], 'primaryOutcomes': [{'measure': 'Vitamin D levels', 'timeFrame': '3 months after taking the drug', 'description': 'Vitamin D levels after supplementation'}], 'secondaryOutcomes': [{'measure': 'RAAS levels', 'timeFrame': '3 months after taking the drug', 'description': 'RAAS levels after vitamin D supplementation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['children ; VVS； vitamin D ; symptom score ; RAAS'], 'conditions': ['Vitamin D']}, 'descriptionModule': {'briefSummary': 'children ; autonomic nervous mediated syncope； vitamin D ; symptom score ; renin-angiotensin-aldosterone-system', 'detailedDescription': "children with autonomic nervous mediated syncope have seriously affects children's physical and mental health and quality of life, and the incidence rate is also increasing year by year. But the current treatment measures are not ideal, Therefore, we need to look for new biological indicators, according to different biological indicators to develop different treatment options, so as to improve the current situation of poor treatment of children with NMS"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children diagnosed with OI;\n* Compliance with the diagnostic guidelines for Syncope in children (2016 edition) and 2018 syncope in children and adolescents in the cardiovascular group of the Society of Pediatrics, Chinese Medical Association The diagnostic criteria of Oi in the Diagnostic and therapeutic guidelines.\n\nExclusion Criteria:\n\n* Taken 3 months prior to admission Vitamin D or hormone drugs;\n* Heart, brain, nerves, metabolism, blood and other apparatus Syncope or aura of syncope caused by a qualitative disease;'}, 'identificationModule': {'nctId': 'NCT04844957', 'briefTitle': "Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope Child and it 's RAAS", 'organization': {'class': 'OTHER', 'fullName': 'LanZhou University'}, 'officialTitle': "Correlation Between Vitamin D and Symptoms Severity of Autonomic Nervous Mediated Syncope（NMS） Child and it 's RAAS", 'orgStudyIdInfo': {'id': '2021A-057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clinical Study of Vitamin D in Children With NMS', 'description': "Correlation between vitamin D and symptoms severity of autonomic nervous mediated syncope child and it 's RAAS", 'interventionNames': ['Drug: Vitamin D', 'Device: Full automatic chemiluminescence measuring instrument']}], 'interventions': [{'name': 'Vitamin D', 'type': 'DRUG', 'otherNames': ['Vitamin D drops'], 'description': 'Clinical Study', 'armGroupLabels': ['Clinical Study of Vitamin D in Children With NMS']}, {'name': 'Full automatic chemiluminescence measuring instrument', 'type': 'DEVICE', 'description': 'Chemiluminescence immunoassay', 'armGroupLabels': ['Clinical Study of Vitamin D in Children With NMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '733000', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yujie Kong, M.D', 'role': 'CONTACT', 'email': '13523396714@163.com', 'phone': '18709316966'}, {'name': 'xiangyu Dong, Professor', 'role': 'CONTACT', 'email': 'dxy0223@163.com', 'phone': '13609370003'}], 'facility': 'Kongyujie', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}], 'centralContacts': [{'name': 'yujie Kong, M.D', 'role': 'CONTACT', 'email': '13523396714@163.com', 'phone': '18709316966'}, {'name': 'xiangyu Dong, Professor', 'role': 'CONTACT', 'email': 'dxy0223@163.com', 'phone': '13609370003'}], 'overallOfficials': [{'name': 'xiangyu Dong, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LanZhou University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Experimental outcomes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kongyujie', 'class': 'OTHER'}, 'collaborators': [{'name': 'LanZhou University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Graduate student', 'investigatorFullName': 'Kongyujie', 'investigatorAffiliation': 'LanZhou University'}}}}