RecruitingPhase 4

Dosing of LT4 in Older Individuals

United States228 participantsStarted 2024-01-31

Plain-language summary

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

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale

Timeframe: 6 months

NCT IDNCT06073665

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04-01

Anne R. Cappola, M.D., Sc.M.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.