Discontinuation of Low-Dose Levothyroxine in Older Adults With Subclinical Hypothyroidism

A vizsgálat adatai

Ki végzi

Spyridoula Maraka

Azonosító

NCT07787585

A regiszteradat frissítve

2026. augusztus 26.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

Discontinuation of Low Dose Levothyroxine Therapy for Older Adults With Subclinical Hypothyroidism: a Randomized, Double-blinded, Placebo-controlled Study

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.

The main questions it aims to answer are:

* Does discontinuing levothyroxine result in no clinically meaningful worsening of thyroid-related symptoms compared with continuing levothyroxine? * What are the effects of discontinuing levothyroxine on quality of life, tiredness, cognition, thyroid hormone levels, lipid levels, weight, and adverse events? * Is discontinuing levothyroxine cost-effective compared with continuing treatment?

Researchers 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.

Participants will:

* Complete a 2-week run-in period during which they continue their usual levothyroxine and record their medication use. * 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. * 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.

Bevonási feltételek: Age ≥65 years; Euthyroid at the time of enrollment, defined as thyroid-stimulating hormone (TSH) and free thyroxine (fT4) levels within the reference range; Receiving levothyroxine treatment for subclinical hypothyroidism for at least 6 months; Receiving levothyroxine at a dose ≤50 mcg/day, or ≤25 mcg/day for participants weighing <50 kg; Receiving outpatient care at the participating study site for at least 12 months; Subclinical hypothyroidism is defined as a TSH level above the normal reference range but <10 mIU/L, with a normal fT4 level, prior to initiation of levothyroxine therapy.

Kizáró feltételek: Levothyroxine therapy initiated less than 6 months before enrollment; Current use of medications that affect thyroid hormone levels, such as antithyroid medications, amiodarone, or lithium; Hospitalization for a major illness or elective surgery within the previous 4 weeks, including acute coronary syndrome, acute myocarditis, pancarditis, or stroke; History of thyroid cancer or goiter with compressive symptoms; History of partial or total thyroidectomy or radioactive iodine therapy; New York Heart Association (NYHA) Class IV heart failure; Unstable medical condition that, in the investigator's judgment, would jeopardize participant safety or interfere with study participation; Terminal illness with a life expectancy of less than 6 months; Uncontrolled psychiatric disorder; Uncontrolled chronic fatigue syndrome; Severe dyslipidemia, defined as LDL cholesterol >190 mg/dL; TSH >10 mIU/L at any time documented in the institutional electronic health record; Abnormal thyroid function at the time of enrollment; Lack of decision-making capacity; Untreated depression; Uncontrolled pain.

ClinicalTrials.gov NCT07787585