[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625557":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":62,"studyPopulation":53,"armGroups":63,"interventions":77,"overallOfficials":53,"centralContacts":91,"locations":101,"responsibleParty":115,"collaborators":119,"id":123,"slug":53,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":53,"eligibilityCriteria":127,"healthyVolunteers":124,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":53,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":144,"whyStopped":53,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"ThyPRO Composite QOL Scale","22 items, scored 0-100, higher scores indicate worse status","6 months",[14,17,20,24,27,30,33,36,39,42],{"measure":15,"description":16,"timeFrame":12},"ThyPRO subscales","ThyPRO hypothyroid symptoms and tiredness subscales, 4 items, scored 0-100, higher scores indicate worse status",{"measure":18,"description":19,"timeFrame":12},"Thyroid Symptoms Questionnaire (TSQ)","Thyroid symptoms scale, 12 items, score range 0-36, higher score indicates worse status",{"measure":21,"description":22,"timeFrame":23},"Cognitive measures","NIH Toolbox Fluid Cognition Score, based around median of 100, higher scores indicate higher function","Baseline and 6 months",{"measure":25,"description":26,"timeFrame":23},"Beck Depression Inventory","21 items, range of 0-63, higher scores indicate more depressive symptoms",{"measure":28,"description":29,"timeFrame":23},"Beck Anxiety Inventory","21 items, range 0-63, higher scores indicate more anxiety",{"measure":31,"description":32,"timeFrame":12},"Pittsburgh Sleep Quality Index","19 items, range of 0-21, higher scores indicate worse sleep",{"measure":34,"description":35,"timeFrame":12},"Weight","Kilograms",{"measure":37,"description":38,"timeFrame":12},"LDL cholesterol","Blood test, g\u002FdL",{"measure":40,"description":41,"timeFrame":12},"Serum c-telopeptide","Blood test, pg\u002FmL",{"measure":43,"description":44,"timeFrame":12},"Satisfaction with randomized status","Participants will be asked if they can guess their randomization status and satisfaction with randomized status",[46],{"measure":47,"description":48,"timeFrame":49},"Symptom checks","Questionnaire of 4 hypothyroid symptoms, higher scores indicate worse function","Weekly for 8 weeks and at months 3, 4, and 5",{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":53,"timePerspective":53,"maskingInfo":55},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":56,"maskingDescription":53,"whoMasked":57},"QUADRUPLE",[58,59,60,61],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",".Participants will\n\n* Take LT4+LT3 or LT4+placebo for 6 months\n* Visit the clinic at the beginning and the end of the study for a blood test and to answer questionnaires.\n* Have blood tests checked at 6 and 13 weeks and symptom checks by text (weekly to monthly)",[64,71],{"label":65,"type":66,"description":67,"interventionNames":68},"LT4+LT3","EXPERIMENTAL","Levothyroxine plus liothyronine therapy",[69,70],"Drug: Liothyronine (L-T3)","Drug: Levothyroxine Sodium (LT4) Tablets",{"label":72,"type":73,"description":74,"interventionNames":75},"LT4+placebo","ACTIVE_COMPARATOR","Levothyroxine plus liothyronine placebo",[70,76],"Drug: Liothyronine (LT3) placebo",[78,83,87],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":53},"DRUG","Liothyronine (L-T3)","Participants will either take LT3 with an LT4 dose that is reduced from baseline or they will take liothyronine placebo with their baseline LT4 dose.",[65],{"type":79,"name":84,"description":85,"armGroupLabels":86,"otherNames":53},"Levothyroxine Sodium (LT4) Tablets","All participants will take levothyroxine.",[65,72],{"type":79,"name":88,"description":89,"armGroupLabels":90,"otherNames":53},"Liothyronine (LT3) placebo","Identical placebo tablet without containing liothyronine",[72],[92,97],{"name":93,"role":94,"phone":95,"phoneExt":53,"email":96},"Anne R. Cappola, MD, ScM","CONTACT","215-573-5359","acappola@pennmedicine.upenn.edu",{"name":98,"role":94,"phone":99,"phoneExt":53,"email":100},"Theresa Scattergood, MSN, RN","215-898-5664","theresa.scattergood@pennmedicine.upenn.edu",[102],{"facility":103,"status":53,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":53},"Penn Medicine, Smilow Center for Translational Resarch,","Philadelphia","Pennsylvania","19104","United States","US",{"type":110,"coordinates":111},"Point",[112,113],-75.16362,39.95238,{"lat":113,"lon":112},{"type":116,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"PRINCIPAL_INVESTIGATOR","Anne Cappola, MD","Professor of Medicine",[120],{"name":121,"class":122},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100625557",false,"NCT07424183","T4\u002FT3 Therapy in Hypothyroidism","Inclusion Criteria:\n\n1. Male or female, aged 18-70 years\n2. Hypothyroidism due to either thyroid failure or total thyroidectomy for structural thyroid disease (nodules, benign goiter, or thyroid cancer) for at least 6 months\n3. Taking 75-150 mcg per day LT4 and a minimum of 1.2 mcg\u002Fkg\u002Fday, with stable dose of LT4 for at least 3 months prior to enrollment\n4. TSH of 0.5 to 4.0 mU\u002FL within 2 months of enrollment\n5. Persistent symptoms for at least 2 months, and a TSQ score of ≥ 5\n6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study intervention.\n\nExclusion Criteria:\n\n1. Current use of LT3, thyroid extracts, Tirosint liquid or capsules, amiodarone, lithium, methimazole, propylthiouracil, supraphysiologic doses of corticosteroids, immunotherapy, tyrosine kinase inhibitors, interferon, or biotin supplements\n2. Diseases of the pituitary or hypothalamus\n3. History of thyroid cancer requiring suppression of TSH secretion\n4. Unstable cardiac conditions, including uncontrolled hypertension (current blood pressure greater than 160\u002F100), arrhythmia, or angina\n5. Uncontrolled psychiatric disorders\n6. Pregnancy or lactation, or planned pregnancy within the next 7 months\n7. History of food dye allergies\n8. GFR \\\u003C30 ml\u002Fmin\u002F1.73 m2\n9. Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study (for example, end-stage cancer)","ALL","18 Years","70 Years",{"count":132,"type":133},60,"ESTIMATED","INTERVENTIONAL",[136],"PHASE2","This study will test whether 6 months of combination therapy with levothyroxine (LT4) plus liothyronine (LT3) is superior to LT4 plus placebo in participants with hypothyroidism who have residual symptoms of hypothyroidism with TSH levels within the reference range.",[139],"Hypothyroidism Primary",[141,142,143],"Hypothyroidism","levothyroxine","liothyronine","NOT_YET_RECRUITING","2026-04-16",{"date":147,"type":148},"2026-04-21","ACTUAL",{"date":150,"type":133},"2026-06",{"date":152,"type":133},"2027-06",{"name":5,"class":6},1]