[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100360751":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of California, Irvine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Levothyroxine","EXPERIMENTAL","Patients will be randomized to levothyroxine or placebo (similar in size, shape, and color to levothyroxine) via permuted blocks stratified by two TSH levels (\\>3.0-5.0 and 5.0-10.0mIU\u002FL) to ensure treatment balance across TSH levels. The study medications will be prepared in pill form. In the treatment arm, initial L-T4 doses will be 25mcg vs. 50mcg among patients whose TSH is \\>3.0-5.0mIU\u002FL vs. 5.0-10.0mIU\u002FL, respectively. Patients in the placebo arm will receive an equivalent number of placebo pills daily depending upon TSH level.\n\nThe intervention period is 24 weeks. Patients will undergo up to two subsequent dose titrations after 8- and 16-weeks of treatment, based on interim TSH measurements at these time points. Patients whose TSH levels are higher or lower than the therapeutic TSH target of 0.5-3.0mIU\u002FL will undergo a dose adjustment (+\u002F- 25mcg), while those whose TSH levels are in target range will continue the prior dose.",[13],"Drug: Levothyroxine Sodium",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients will be randomized to levothyroxine or placebo (similar in size, shape, and color to levothyroxine) via permuted blocks stratified by two TSH levels (\\>3.0-5.0 and 5.0-10.0mIU\u002FL) to ensure treatment balance across TSH levels. The study medications will be prepared in pill form. In the treatment arm, initial L-T4 doses will be 25mcg vs. 50mcg among patients whose TSH is \\>3.0-5.0mIU\u002FL vs. 5.0-10.0mIU\u002FL, respectively. Patients in the placebo arm will receive an equivalent number of placebo pills daily depending upon TSH level.\n\nThe intervention period is 24 weeks. Patients in the placebo arm will undergo an equivalent titration in placebo pills (as that of the experimental arm) after 8- and 16-weeks of treatment, based on interim TSH measurements at these time points.",[19],"Drug: Placebos",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Levothyroxine Sodium","Thyroid hormone supplement",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebos","Placebo oral capsule",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Connie Rhee, MD, MSc","CONTACT","714-456-5142","crhee1@uci.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of California Irvine","RECRUITING","Orange","California","92868","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-117.85311,33.78779,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},"Kamyar Kalantar-Zadeh","7144565142","kkz@uci.edu",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Connie Rhee","Assistant Professor of Medicine and Public Health; Division of Nephrology and Hypertension, Department of Medicine",[62],{"name":63,"class":64},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100360751","a-randomized-controlled-trial-of-thyroid-hormone-supplementation-in-hemodialysis-patients-100360751",false,"NCT03977207","A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients","THYROID-HD","Inclusion Criteria:\n\n* Age 18-75 years old\n* Received hemodialysis at least four weeks\n* Have two consecutive thyrotropin (TSH) levels \\>3.0-10.0mIU\u002FL during the screening period\n* Have normal free thyroxine (FT4) levels\n* Have ability to provide written informed consent\n\nExclusion Criteria:\n\n* Active treatment with thyroid hormone supplementation or anti-thyroid medications\n* Active receipt of dialysis\n* Prior kidney transplantation\n* Life expectancy less than six months\n* Active malignancy or prior thyroid malignancy\n* Active pregnancy or planning a pregnancy\n* Active coronary ischemia or atrial fibrillation (evaluated by EKG)\n* Active congestive heart failure exacerbation\n* Osteoporosis\n* Weight in excess of 450 lbs.\n* Hyperthyroidism as determined by TSH \\\u003C0.5mIU\u002FL during the screening period, anti-thyroid medication use, or hyperthyroidism diagnosis","ALL","18 Years","75 Years",{"count":76,"type":77},336,"ESTIMATED","INTERVENTIONAL",[80],"NA","Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication in chronic kidney disease patients, and prior evidence shows that higher TSH levels, even within the normal laboratory range, are strongly associated with impaired quality of life and cardiovascular disease in this population. Levothyroxine is one of the most frequently prescribed medications in chronic kidney disease, yet its efficacy and safety in these patients have not been well-studied. Hence, this study will investigate 1) whether levothyroxine improves patient-centered (e.g., health-related quality of life, physical performance, strength) and 2) cardiovascular (e.g., coronary artery calcification, endothelial function, systolic function) outcomes in dialysis patients, and 3) if thyroid hormone replacement exerts classic metabolic effects (i.e., changes in body fat and resting energy expenditure) in this population.",[83,84,85],"Thyroid; Functional Disturbance","Hypothyroidism","Hemodialysis","2025-08-30",{"date":88,"type":89},"2025-09-08","ACTUAL",{"date":91,"type":89},"2020-07-20",{"date":93,"type":77},"2025-11-30",{"name":5,"class":6},1]