Dosing of LT4 in Older Individuals

Recruiting now · Phase 4

Conditions studied: Hypothyroidism

In brief

Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.

Key facts

Study ID: NCT06073665
Run by: University of Pennsylvania
People needed: 228
Starts: 2024-01-31
Expected to finish: 2028-04-01
Last updated by the study team: 2026-02-19

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, community dwelling, aged 65 years or older
Diagnosed with hypothyroidism of any etiology for at least 6 months, taking 75-200 mcg per day LT4 and a minimum of 1.2 mcg/kg/day with no dose adjustment since the last TSH test.
Ability to take oral medication and be willing to adhere to the medication regimen
Adherence to lifestyle considerations.

You may not qualify if…

Hypopituitarism
History of thyroid cancer requiring suppression of TSH secretion
Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests
GFR <30 ml/min/1.73 m2 within the prior 12 months
Unable to understand and comply with study requirements, as assessed by study staff and the PI, will be excluded.
Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study.
Currently taking multikinase or checkpoint inhibitor therapy.
Any history of food dye allergy.

Where it is running

Penn Medicine, Smilow Translational Research Center — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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