Recruiting

LT4

Sponsor:

University of Pennsylvania

Code:

NCT06073665

Conditions

Hypothyroidism

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Levothyroxine Sodium

Study Details

Brief summary:

Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.

Conditions

Hypothyroidism

Study ID

NCT06073665

Start date

Jan 31, 2024

Status verified date

Feb, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

228 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Levothyroxine Sodium

Levothyroxine dose will depend on dose at baseline and randomization group

Primary outcome measure

  • Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Penn Medicine, Smilow Translational Research Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • Levothyroxine Dosing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-19.