RecruitingPhase 4NCT06073665

Dosing of LT4 in Older Individuals

Levothyroxine Dosing in Older Individuals

Sponsor

University of Pennsylvania

Enrollment

228 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

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.

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.

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DRUGLevothyroxine Sodium

Levothyroxine dose will depend on dose at baseline and randomization group

Penn Medicine, Smilow Translational Research Center

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06073665