Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-01 @ 10:24 PM
Study NCT ID:
NCT04942769
Status:
UNKNOWN
Last Update Posted:
2021-07-16
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Effect of Selenium Supplementation on the Structure and Function of Autoimmune Thyroiditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012643', 'term': 'Selenium'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'patients with Autoimmune thyroiditis'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-11', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anti-thyroglobulin antibody changes', 'timeFrame': 'Changes from baseline and 3 months during follow-up', 'description': 'Changes from baseline and 3 months during follow-up'}, {'measure': 'T1-mapping values of Thyroid MRI', 'timeFrame': 'Changes from baseline and 3 months during follow-up', 'description': 'Changes from baseline and 3 months during follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Selenium']}, 'descriptionModule': {'briefSummary': 'To evaluate the effects of exogenous selenium supplementation on autoimmune thyroiditis.', 'detailedDescription': 'In patients with autoimmune thyroiditis， investigators compared changes in thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping values and metabolic indicatorsfrom baseline to the end of treatment (12 weeks)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women between the ages of 18 and 75\n* Clinical diagnosis of autoimmune thyroiditis, serum TPOAb and TGAB positive\n* Thyroid function is normal, and no drugs affecting thyroid function such as Umetole and Serge have been used\n\nExclusion Criteria:\n\n* The contraindications indicated in the Chinese instructions of the drug\n* Hypothyroidism, hyperthyroidism\n* Liver function impairment\n* Renal function impairment\n* Claustrophobia\n* Mental disorders'}, 'identificationModule': {'nctId': 'NCT04942769', 'briefTitle': 'Study on the Effect of Selenium Supplementation on the Structure and Function of Autoimmune Thyroiditis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Study on the Effect of Selenium Supplementation on the Structure and Function of Autoimmune Thyroiditis', 'orgStudyIdInfo': {'id': '2021-310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'selenium', 'description': 'selenium was administered to patients with autoimmune thyroiditis', 'interventionNames': ['Drug: Selenium']}], 'interventions': [{'name': 'Selenium', 'type': 'DRUG', 'description': 'selenium 100ug ，take it orally twice daily', 'armGroupLabels': ['selenium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jia liu, MD', 'role': 'CONTACT', 'email': 'liujia0116@126.com', 'phone': '861085231710'}], 'facility': 'Beijing Chao-Yang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jia Liu, MD', 'role': 'CONTACT', 'email': 'liujia0116@126.com', 'phone': '861085231710'}, {'name': 'Xiaomeng Sun', 'role': 'CONTACT', 'email': 'beijingxiaosun2010@163.com', 'phone': '861085231711'}], 'overallOfficials': [{'name': 'Guang Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chao Yang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director, Department of Endocrinology', 'investigatorFullName': 'Guang Wang', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}