Levothyroxine Dosing in Older Individuals
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
Pennsylvania
Penn Medicine, Smilow Translational Research Center
RECRUITING
Philadelphia
Contact Information
Primary
Anne R. Cappola, M.D., Sc.M.
acappola@pennmedicine.upenn.edu
215-573-5359
Backup
Theresa M. Scattergood, M.S.N., R.N.
theresa.scattergood@pennmedicine.upenn.edu
215-898-5664
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2028-04-01
Participants
Target number of participants: 228
Treatments
Active_comparator: Lower TSH Group
Target TSH level of 0.5-2.0 mU/L
Experimental: Higher TSH group
Target TSH level of 5.5-7.0 mU/L
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania
Collaborators: National Institute on Aging (NIA)