Clinical trial NCT06073665: Dosing of LT4 in Older Individuals
Official title: Levothyroxine Dosing in Older Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypothyroidism
Keywords: Levothyroxine Dosing
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-10-10
Enrollment: 228
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, parallel, double-blind clinical trial of two 6-month dosing strategies of levothyroxine (LT4)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale
timeFrame: 6 months
Secondary outcomes:
measure: Thyroid-Related Quality of Life Patient-Reported Outcome Hypothyroidism subscale b. ThyPRO "Tiredness" subscale c. Thyroid Symptoms Questionnaire (TSQ)
timeFrame: 6 months
measure: NIH Toolbox Fluid Cognition Composite Score
timeFrame: 6 months
measure: Geriatric Depression Scale
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 months
measure: Weight
timeFrame: 6 months
measure: LDL cholesterol
timeFrame: 6 months
measure: Satisfaction with randomized status
timeFrame: 6 months
measure: Beck Anxiety Inventory
timeFrame: 6 months
measure: Serum c-telopeptide (CTX)
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine, Smilow Translational Research Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Anne R. Cappola, M.D., Sc.M.
role: PRINCIPAL_INVESTIGATOR
References: