Dosing of LT4 in Older Individuals
- Registration Number
- NCT06073665
- Lead Sponsor
- University of Pennsylvania
- 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 stable dose of at least 1.2 mcg/kg/day of LT4 therapy, one to maintain a target thyroid stimulating hormone (TSH) level of 0.5-2.0 mU/L (lower TSH group) and another of a lower levothyroxine dose to achieve a target TSH of 5.5-7.0 mU/L (higher TSH group). Investigators will assess the effects of levothyroxine therapy at two different TSH targets on symptoms of hypothyroidism, mood, sleep, measures of memory and executive function, weight, lipids, and a marker of bone turnover.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 228
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lower TSH Group Levothyroxine Sodium Target TSH level of 0.5-2.0 mU/L Higher TSH group Levothyroxine Sodium Target TSH level of 5.5-7.0 mU/L
- Primary Outcome Measures
Name Time Method Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale 6 months 22 items, scored 0-100, higher scores indicate worse status
- Secondary Outcome Measures
Name Time Method Thyroid-Related Quality of Life Patient-Reported Outcome Hypothyroidism subscale b. ThyPRO "Tiredness" subscale c. Thyroid Symptoms Questionnaire (TSQ) 6 months 4 items, scored 0-100, higher scores indicate worse status
Pittsburgh Sleep Quality Index 6 months 19 items, range of 0-21, higher scores indicate worse sleep
Weight 6 months kilograms
LDL cholesterol 6 months blood test, g/dL
Beck Anxiety Inventory 6 months Beck Anxiety Inventory, 21 items, range 0-63, higher scores indicate more anxiety
Serum c-telopeptide (CTX) 6 months Blood test, pg/mL
NIH Toolbox Fluid Cognition Composite Score 6 months Adjusted scale score, based around median of 100, higher scores indicated higher function
Geriatric Depression Scale 6 months 30 items, higher scores indicate more depressive symptoms
Satisfaction with randomized status 6 months Participants will be asked if they can guess their randomization status and satisfaction with randomization status
Trial Locations
- Locations (1)
Penn Medicine, Smilow Translational Research Center
🇺🇸Philadelphia, Pennsylvania, United States