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RECRUITINGPhase 4INTERVENTIONAL

Dosing of LT4 in Older Individuals

Levothyroxine Dosing in Older Individuals

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 1. Provision of signed and dated willing to sign a consent form form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, community dwelling, aged 65 years or older 4. 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. 5. Ability to take oral medication and be willing to adhere to the medication regimen 6. Adherence to lifestyle considerations. Who Should NOT Join This Trial: 1. Hypopituitarism 2. History of thyroid cancer requiring suppression of TSH secretion 3. Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests 4. GFR \<30 ml/min/1.73 m2 within the prior 12 months 5. Unable to understand and comply with study requirements, as assessed by study staff and the PI, will be excluded. 6. Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study. 7. Currently taking multikinase or checkpoint inhibitor therapy. 8. Any history of food dye allergy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, community dwelling, aged 65 years or older 4. 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. 5. Ability to take oral medication and be willing to adhere to the medication regimen 6. Adherence to lifestyle considerations. Exclusion Criteria: 1. Hypopituitarism 2. History of thyroid cancer requiring suppression of TSH secretion 3. Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests 4. GFR \<30 ml/min/1.73 m2 within the prior 12 months 5. Unable to understand and comply with study requirements, as assessed by study staff and the PI, will be excluded. 6. Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study. 7. Currently taking multikinase or checkpoint inhibitor therapy. 8. Any history of food dye allergy.

Treatments Being Tested

DRUG

Levothyroxine Sodium

Levothyroxine dose will depend on dose at baseline and randomization group

Locations (1)

Penn Medicine, Smilow Translational Research Center
Philadelphia, Pennsylvania, United States