Hypothyroidism
Conditions
Keywords
Levothyroxine Dosing
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.
Interventions
Levothyroxine dose will depend on dose at baseline and randomization group
Sponsors
University of Pennsylvania
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
overencapsulated levothyroxine doses will be provided by the investigational drug pharmacy
Intervention model description
randomized, parallel, double-blind clinical trial of two 6-month dosing strategies of levothyroxine (LT4)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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 6. Adherence to lifestyle considerations.
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. 7. Currently taking multikinase or checkpoint inhibitor therapy. 8. Any history of food dye allergy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Satisfaction with randomized status | 6 months | Participants will be asked if they can guess their randomization status and satisfaction with randomization status |
| 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 |
Countries
United States
Contacts
CONTACTAnne R. Cappola, M.D., Sc.M.
CONTACTTheresa M. Scattergood, M.S.N., R.N.
PRINCIPAL_INVESTIGATORAnne R. Cappola, M.D., Sc.M.
University of Pennsylvania
Outcome results
None listed