Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT06726967
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D, Hashimato's Thyroiditis and Thyroid Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin D 25 OH D', 'timeFrame': 'Baseline', 'description': 'nmol/L'}, {'measure': 'thyroid-stimulating hormone (TSH)', 'timeFrame': 'Baseline', 'description': 'uIU/mL'}, {'measure': 'free thyroxine (fT4)', 'timeFrame': 'Baseline', 'description': 'ng/dL'}, {'measure': 'Anti-thyroid peroxidase (anti-TPO)', 'timeFrame': 'Baseline', 'description': 'IU/mL'}, {'measure': 'anti-thyroglobulin (anti-TG)', 'timeFrame': 'Baseline', 'description': 'IU/mL'}], 'secondaryOutcomes': [{'measure': 'free triiodothyronine (fT3)', 'timeFrame': 'Baseline', 'description': 'pg/ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitamin D', 'Thyroid autoimmunity', "hashimato's thyroiditis", 'thyroid functions'], 'conditions': ['Vitamin D', 'Thyroid Autoimmune Disease']}, 'descriptionModule': {'briefSummary': "The goal of this retrospective observational study is to determine whether vitamin D levels differ in patients with Hashimoto's thyroiditis (HT) compared to those without Hashimoto's thyroiditis. The main research questions are:\n\nAre vitamin D levels lower in HT patients compared to non-HT patients? Do vitamin D levels vary between HT and non-HT patients based on thyroid function status?\n\nThe study was conducted by retrospectively reviewing the medical records of patients who visited the hospital outpatient clinic."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who apply to the Endocrinology Clinic of Ankara Bilkent City Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with the following biochemical parameters:\n\n* Vitamin D (25(OH)D) levels\n* Thyroid-stimulating hormone (TSH) levels\n* Free triiodothyronine (fT3) levels\n* Free thyroxine (fT4) levels\n* Anti-thyroid peroxidase (anti-TPO) levels\n* Anti-thyroglobulin (anti-Tg) levels\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06726967', 'briefTitle': "Vitamin D, Hashimato's Thyroiditis and Thyroid Functions", 'organization': {'class': 'OTHER', 'fullName': 'Ankara Yildirim Beyazıt University'}, 'officialTitle': 'The Relationship Between Vitamin D Levels, Thyroid Functions, and Thyroid Autoimmunity', 'orgStudyIdInfo': {'id': 'AnkaraYBU-KARAKAYA005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults', 'description': 'Patients with thyroid function tests (thyroid-stimulating hormone (TSH), free T3 (fT3), free T4 (fT4)), thyroid antibodies (anti-Tg, anti-TPO), and 25(OH) vitamin D levels', 'interventionNames': ['Diagnostic Test: vitamin D 25(OH)D']}], 'interventions': [{'name': 'vitamin D 25(OH)D', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Thyroid functions', 'Thyroid antibodies'], 'description': 'Thyroid functions (thyroid-stimulating hormone (TSH), serbest triiodothyronine (fT3), serbest thyroxine (fT4)); Thyroid antibodies (Anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (anti-TG))', 'armGroupLabels': ['Adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Çankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Rahime E Karakaya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara Yildirim Beyazıt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Yildirim Beyazıt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rahime Evra KARAKAYA', 'investigatorAffiliation': 'Ankara Yildirim Beyazıt University'}}}}