[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521751":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":54,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lower TSH Group","ACTIVE_COMPARATOR","Target TSH level of 0.5-2.0 mU\u002FL",[13],"Drug: Levothyroxine Sodium",{"label":15,"type":16,"description":17,"interventionNames":18},"Higher TSH group","EXPERIMENTAL","Target TSH level of 5.5-7.0 mU\u002FL",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Levothyroxine Sodium","Levothyroxine dose will depend on dose at baseline and randomization group",[15,9],null,[27],{"name":28,"affiliation":5,"role":29},"Anne R. Cappola, M.D., Sc.M.","PRINCIPAL_INVESTIGATOR",[31,35],{"name":28,"role":32,"phone":33,"phoneExt":25,"email":34},"CONTACT","215-573-5359","acappola@pennmedicine.upenn.edu",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Theresa M. Scattergood, M.S.N., R.N.","215-898-9275","theresa.scattergood@pennmedicine.upenn.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"Penn Medicine, Smilow Translational Research Center","RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-75.16362,39.95238,{"lat":52,"lon":51},{"type":29,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Anne Cappola, MD","Professor of Medicine, Division of Endocrinology, Diabetes and Metabolism",[58],{"name":59,"class":60},"National Institute on Aging (NIA)","NIH","100521751","phase-4-dosing-of-lt4-in-older-individuals-100521751",false,"NCT06073665","Dosing of LT4 in Older Individuals","Levothyroxine Dosing in Older Individuals","DOT4","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, community dwelling, aged 65 years or older\n4. Diagnosed with hypothyroidism of any etiology for at least 6 months, taking 75-200 mcg per day LT4 and a minimum of 1.2 mcg\u002Fkg\u002Fday with no dose adjustment since the last TSH test.\n5. Ability to take oral medication and be willing to adhere to the medication regimen\n6. Adherence to lifestyle considerations.\n\nExclusion Criteria:\n\n1. Hypopituitarism\n2. History of thyroid cancer requiring suppression of TSH secretion\n3. Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests\n4. GFR \\\u003C30 ml\u002Fmin\u002F1.73 m2 within the prior 12 months\n5. Unable to understand and comply with study requirements, as assessed by study staff and the PI, will be excluded.\n6. Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study.\n7. Currently taking multikinase or checkpoint inhibitor therapy.\n8. Any history of food dye allergy.","ALL","65 Years",{"count":72,"type":73},228,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.",[79],"Hypothyroidism",[81],"Levothyroxine Dosing","2026-02-17",{"date":84,"type":85},"2026-02-19","ACTUAL",{"date":87,"type":85},"2024-01-31",{"date":89,"type":73},"2028-04-01",{"name":5,"class":6},1]