Levothyroxine Dosing in Older Individuals with Hypothyroidism to Compare Two TSH Target Levels

What this Trial Is About

Researchers are studying the effects of different dosing strategies of levothyroxine (LT4) in people aged 65 and older who have hypothyroidism and are already taking a stable dose of LT4. The study aims to understand the clinical outcomes of allowing more flexibility in LT4 dosing by targeting two different thyroid stimulating hormone (TSH) levels. This trial is a randomized, double-blind, parallel-group study evaluating how these dosing strategies impact symptoms, mood, sleep, memory, weight, cholesterol, and bone health. Participants will be randomly assigned to one of two groups for six months: one group will have their LT4 dose adjusted to maintain a TSH level between 0.5 and 2.0 mU/L (lower TSH group), and the other will have a lower LT4 dose to reach a TSH level between 5.5 and 7.0 mU/L (higher TSH group). Levothyroxine dosing will be tailored based on baseline dose and group assignment, and treatment is given orally. The study involves careful monitoring of thyroid hormone levels and symptoms throughout the treatment period. During the study, participants will undergo assessments including quality of life questionnaires focused on thyroid health, mood and depression scales, sleep quality measures, cognitive tests, weight and cholesterol checks, and bone turnover markers. These evaluations will happen at the start and after six months of treatment. Researchers will track how well participants follow the medication regimen and lifestyle recommendations. The study is sponsored by the University of Pennsylvania and plans to run through April 2028.

Dosing of LT4 in Older Individuals