RECRUITING

Dosing of LT4 in Older Individuals

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Conditions

HypothyroidismLevothyroxine Dosing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Levothyroxine Dosing in Older Individuals

Quick Facts

Study Start:2024-01-31
Study Completion:2028-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06073665

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Male or female, community dwelling, aged 65 years or older
  4. 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. 5. Ability to take oral medication and be willing to adhere to the medication regimen
  1. 1. Hypopituitarism
  2. 2. History of thyroid cancer requiring suppression of TSH secretion
  3. 3. Current use of liothyronine (LT3), thyroid extracts, Tirosint liquid or capsules, and medications that interfere with thyroid function or thyroid function tests
  4. 4. GFR \<30 ml/min/1.73 m2 within the prior 12 months
  5. 5. Unable to understand and comply with study requirements, as assessed by study staff and the PI, will be excluded.
  6. 6. Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study.

Contacts and Locations

Study Contact

Anne R. Cappola, M.D., Sc.M.
CONTACT
215-573-5359
acappola@pennmedicine.upenn.edu
Theresa M. Scattergood, M.S.N., R.N.
CONTACT
215-898-5664
theresa.scattergood@pennmedicine.upenn.edu

Principal Investigator

Anne R. Cappola, M.D., Sc.M.
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Penn Medicine, Smilow Translational Research Center
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Anne R. Cappola, M.D., Sc.M., PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-31
Study Completion Date2028-04-01

Study Record Updates

Study Start Date2024-01-31
Study Completion Date2028-04-01

Terms related to this study

Keywords Provided by Researchers

  • Levothyroxine Dosing

Additional Relevant MeSH Terms

  • Hypothyroidism