Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2025-12-31 @ 12:42 AM
Study NCT ID:
NCT01102205
Status:
COMPLETED
Last Update Posted:
2013-06-13
First Post:
2010-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050031', 'term': 'Hashimoto Disease'}], 'ancestors': [{'id': 'D013967', 'term': 'Thyroiditis, Autoimmune'}, {'id': 'D013966', 'term': 'Thyroiditis'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'after overnight fasting state,venous blood will be taken to obtain serum.speciemens stored -70 cantigrade celcius untillanalysing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-11', 'studyFirstSubmitDate': '2010-04-09', 'studyFirstSubmitQcDate': '2010-04-12', 'lastUpdatePostDateStruct': {'date': '2013-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Poxidative stress markers', 'timeFrame': 'After levotren therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hashimoto Disease']}, 'descriptionModule': {'briefSummary': 'Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of levothyroxine therapy on oxidative balance are also not known in hashimoto disease.', 'detailedDescription': 'oxidative stress markers will be measured initially(TAS,TOS,OSI,PARAOXONASE,ARYLESTERASA,PON1 PHENOTYPİNG,LİPİDPEROXİD).After 3 months therapy with levothyroxine measurements will be repeated except PON1 phenotyping.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult with Hashimoto disease in euthyroid or subclinical hypothyroid state and healthy control.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age more than 18 years\n\nExclusion Criteria:\n\n* inability to give a written consent\n* other conditions and drug usage affect oxidative stress'}, 'identificationModule': {'nctId': 'NCT01102205', 'briefTitle': 'Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease', 'organization': {'class': 'OTHER', 'fullName': 'Vakif Gureba Training and Research Hospital'}, 'officialTitle': 'Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease', 'orgStudyIdInfo': {'id': 'tastoshashi'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy'}, {'label': 'euthyroid hashimoto'}, {'label': 'hypothyroid hashimoto'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34100', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Vakif Gureba Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mehmet ali Cikrikcioglu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'vakif gureba TRH,fatih,istanbul,turkey.specialist in internal medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vakif Gureba Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vakif Gureba TRH', 'investigatorFullName': 'Mehmet Ali Cikrikcioglu', 'investigatorAffiliation': 'Vakif Gureba Training and Research Hospital'}}}}