Flexible dosing of levothyroxine in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effects of two different dosing strategies of levothyroxine (LT4) in older individuals aged 65 and above who are already on stable LT4 therapy. Participants will be randomly assigned to either a lower target thyroid stimulating hormone (TSH) level of 0.5-2.0 mU/L or a higher target of 5.5-7.0 mU/L for a duration of six months. The study will assess various outcomes including symptoms of hypothyroidism, mood, sleep quality, cognitive function, weight, lipid levels, and bone turnover markers.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Anne R. Cappola, M.D., Sc.M. — University of Pennsylvania
• Study coordinator: Anne R. Cappola, M.D., Sc.M.
• Email: acappola@pennmedicine.upenn.edu
• Phone: 215-573-5359

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.