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Search / Trial NCT06073665

Dosing of LT4 in Older Individuals

Launched by UNIVERSITY OF PENNSYLVANIA · Oct 2, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Levothyroxine Dosing

ClinConnect Summary

The clinical trial titled "Dosing of LT4 in Older Individuals" is investigating how flexible dosing of a medication called Levothyroxine (LT4) can affect older adults with hypothyroidism, a condition where the thyroid gland doesn't produce enough hormones. The goal is to see if allowing patients to adjust their LT4 doses can lead to better health outcomes. This study is currently looking for participants who are 65 years or older, have been diagnosed with hypothyroidism for at least six months, and are taking a specific daily dose of LT4 without changes since their last thyroid test.

To participate, individuals must be able to understand and agree to the study requirements, be able to take oral medications, and not have certain other health conditions, like thyroid cancer or severe kidney issues. If you join the study, you will be monitored closely to see how the flexible dosing affects your health. This research aims to improve treatment options for older adults with hypothyroidism, potentially leading to better management of their condition.

Gender

ALL

Eligibility criteria

  • 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
  • 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.

About University Of Pennsylvania

The University of Pennsylvania, a prestigious Ivy League institution located in Philadelphia, is renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and cutting-edge facilities to conduct innovative studies across various therapeutic areas. With a focus on translating scientific discoveries into clinical applications, the University of Pennsylvania fosters collaborations among leading researchers, clinicians, and industry partners, ensuring rigorous trial design and adherence to ethical standards. Through its dedication to excellence in research and education, the university plays a pivotal role in shaping the future of medicine.

Locations

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

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

Principal Investigator

University of Pennsylvania

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported