[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Spyridoula Maraka\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100653581","phase-4-discontinuation-of-low-dose-levothyroxine-in-older-adults-with-subclinical-hypothyroidism-100653581",false,"NCT07787585","Discontinuation of Low-Dose Levothyroxine in Older Adults With Subclinical Hypothyroidism","Discontinuation of Low Dose Levothyroxine Therapy for Older Adults With Subclinical Hypothyroidism: a Randomized, Double-blinded, Placebo-controlled Study","Inclusion Criteria:\n\n1. Age ≥65 years.\n2. Euthyroid at the time of enrollment, defined as thyroid-stimulating hormone (TSH) and free thyroxine (fT4) levels within the reference range.\n3. Receiving levothyroxine treatment for subclinical hypothyroidism for at least 6 months.\n4. Receiving levothyroxine at a dose ≤50 mcg\u002Fday, or ≤25 mcg\u002Fday for participants weighing \\\u003C50 kg.\n5. Receiving outpatient care at the participating study site for at least 12 months.\n\nSubclinical hypothyroidism is defined as a TSH level above the normal reference range but \\\u003C10 mIU\u002FL, with a normal fT4 level, prior to initiation of levothyroxine therapy.\n\nExclusion Criteria:\n\n1. TSH \\>10 mIU\u002FL at any time documented in the institutional electronic health record.\n2. Levothyroxine therapy initiated less than 6 months before enrollment.\n3. Abnormal thyroid function at the time of enrollment.\n4. Current use of medications that affect thyroid hormone levels, such as antithyroid medications, amiodarone, or lithium.\n5. History of thyroid cancer or goiter with compressive symptoms.\n6. History of partial or total thyroidectomy or radioactive iodine therapy.\n7. New York Heart Association (NYHA) Class IV heart failure.\n8. Hospitalization for a major illness or elective surgery within the previous 4 weeks, including acute coronary syndrome, acute myocarditis, pancarditis, or stroke.\n9. Unstable medical condition that, in the investigator's judgment, would jeopardize participant safety or interfere with study participation.\n10. Terminal illness with a life expectancy of less than 6 months.\n11. Lack of decision-making capacity.\n12. Severe dyslipidemia, defined as LDL cholesterol \\>190 mg\u002FdL.\n13. Untreated depression.\n14. Uncontrolled psychiatric disorder.\n15. Uncontrolled chronic fatigue syndrome.\n16. Uncontrolled pain.","ALL","65 Years",{"count":19,"type":20},138,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this clinical trial is to learn whether low-dose levothyroxine can be safely discontinued in adults aged 65 years or older who are taking levothyroxine for subclinical hypothyroidism. The study will also evaluate the cost-effectiveness of discontinuing levothyroxine.\n\nThe main questions it aims to answer are:\n\n* Does discontinuing levothyroxine result in no clinically meaningful worsening of thyroid-related symptoms compared with continuing levothyroxine?\n* What are the effects of discontinuing levothyroxine on quality of life, tiredness, cognition, thyroid hormone levels, lipid levels, weight, and adverse events?\n* Is discontinuing levothyroxine cost-effective compared with continuing treatment?\n\nResearchers will compare participants who discontinue levothyroxine and receive placebo with participants who continue their current dose of levothyroxine to determine the effects of levothyroxine discontinuation.\n\nParticipants will:\n\n* Complete a 2-week run-in period during which they continue their usual levothyroxine and record their medication use.\n* Eligible participants will be randomly assigned to either continue their current dose of levothyroxine or receive a matching placebo for 6 months. Participants, their clinicians, and study investigators will not know which treatment they are receiving during the study.\n* Complete study assessments at baseline, approximately 2 months, and 6 months. Assessments will include blood tests, measurements such as body weight, questionnaires about thyroid-related symptoms and quality of life, and assessments of cognition and other health outcomes.",[26],"Hypothyroidism",[28,29,30,31,32],"subclinical hypothyroidism","levothyroxine","deprescribing","thyroid-related symptoms","older adults","NOT_YET_RECRUITING","2026-08-21",{"date":36,"type":37},"2026-08-26","ACTUAL",{"date":39,"type":20},"2027-10",{"date":41,"type":20},"2031-09",{"name":43,"class":44},"Spyridoula Maraka","OTHER",3,""]