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Recruiting NCT06073665

Dosing of LT4 in Older Individuals

Phase IV Interventional Hypothyroidism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Levothyroxine Sodium.
Who it may be relevant to
Registry conditions: Hypothyroidism. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Levothyroxine Dosing in Older Individuals

Overview

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

  • Drug Levothyroxine Sodium
    Levothyroxine dose will depend on dose at baseline and randomization group

Primary outcome measures

  • Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale [Time frame: 6 months]
Secondary outcome measures (9)
  • Thyroid-Related Quality of Life Patient-Reported Outcome Hypothyroidism subscale b. ThyPRO "Tiredness" subscale c. Thyroid Symptoms Questionnaire (TSQ) [Time frame: 6 months]
  • NIH Toolbox Fluid Cognition Composite Score [Time frame: 6 months]
  • Geriatric Depression Scale [Time frame: 6 months]
  • Pittsburgh Sleep Quality Index [Time frame: 6 months]
  • Weight [Time frame: 6 months]
  • LDL cholesterol [Time frame: 6 months]
  • Satisfaction with randomized status [Time frame: 6 months]
  • Beck Anxiety Inventory [Time frame: 6 months]
  • Serum c-telopeptide (CTX) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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
  • Adherence to lifestyle considerations.

Exclusion criteria

  • 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.
  • Currently taking multikinase or checkpoint inhibitor therapy.
  • Any history of food dye allergy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Penn Medicine, Smilow Translational Research Center — Philadelphia

Identifiers

NCT: NCT06073665 · 1R01AG081698-01, #853300 · R01AG081698

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗