Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-03 @ 3:12 AM
Study NCT ID:
NCT04953195
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2021-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-03', 'studyFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2021-07-03', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thyroid Stimulating Hormone changes', 'timeFrame': 'Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up', 'description': 'Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up'}, {'measure': 'free thyroxine changes', 'timeFrame': 'free thyroxine changes from baseline and 12 weeks during follow-up', 'description': 'free thyroxine changes from baseline and 12 weeks during follow-up'}, {'measure': 'T1-mapping values of Thyroid MRI', 'timeFrame': 'T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up', 'description': 'T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up'}, {'measure': 'Free triiodothyronine changes', 'timeFrame': 'Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up', 'description': 'Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up'}], 'secondaryOutcomes': [{'measure': 'anti-thyroid peroxidase antibody changes', 'timeFrame': 'anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up', 'description': 'anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up'}, {'measure': 'anti-thyroglobulin antibody changes', 'timeFrame': 'anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up', 'description': 'anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subclinical Hypothyroidisms']}, 'descriptionModule': {'briefSummary': 'The purpose of this experiment is to compared the changes of thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping and various metabolic indexes from baseline to the end of treatment (after the thyroid function had been normal for more than three months)', 'detailedDescription': 'In patients with autoimmune thyroiditis with mild subclinical hypothyroidism, the study period will include a screening period of not more than 30 days, and a 12-week treatment period compared to baseline. At completion of treatment, Thyroid Stimulating Hormone(TSH), free thyroxine (FT4)，free thyroxine (FT3) will be included. The changes of anti-thyroglobulin antibody, anti-thyroglobulin antibody, T1-mapping and metabolic indexes.'}, '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* Diagnostic criteria for mild subclinical hypothyroidism :TSH\\>10mIU/L, thyroxine and free thyroxine levels were normal\n* Positive thyroglobulin antibody and/or Thyroperoxidase antibody\n* No previous use of drugs affecting thyroid function\n\nExclusion Criteria:\n\n* The contraindications indicated in the Chinese instructions of the drug\n* Liver function impairment\n* Renal function impairment\n* Claustrophobia\n* Mental disorders'}, 'identificationModule': {'nctId': 'NCT04953195', 'briefTitle': 'Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Effect of Thyroid Replacement Therapy on Thyroid Structure in Patients With Subclinical Hypothyroidism', 'orgStudyIdInfo': {'id': '2021-309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'levothyroxine sodium', 'description': 'levothyroxine sodium', 'interventionNames': ['Drug: Levothyroxine Sodium Tablets']}], 'interventions': [{'name': 'Levothyroxine Sodium Tablets', 'type': 'DRUG', 'description': 'Levothyroxine Sodium(50ug/Tablets,dosage form 25ug,once a day) was administered to patients with autoimmune thyroiditis with mild subclinical hypothyroidism,', 'armGroupLabels': ['levothyroxine sodium']}]}, '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, MD', 'role': 'CONTACT', 'email': 'beijingxiaosun2010@163.com', 'phone': '861085231711'}], 'overallOfficials': [{'name': 'Guang Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chao-Yang Hospital, Capital Medical University, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Endocrinology', 'investigatorFullName': 'Guang Wang', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}