Status:
RECRUITING
Dosing of LT4 in Older Individuals
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Hypothyroidism
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.
Detailed Description
Investigators will perform a randomized, parallel, double-blind clinical trial of two 6-month dosing strategies of levothyroxine (LT4) in patients aged 65 years and older who are already taking a stab...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT06073665
Start Date
January 31 2024
End Date
April 1 2028
Last Update
February 28 2025
Active Locations (1)
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1
Penn Medicine, Smilow Translational Research Center
Philadelphia, Pennsylvania, United States, 19104