Dosing of LT4 in Older Individuals

NCT ID: NCT06073665

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2028-04-01

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.

Conditions

Hypothyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lower TSH Group

Target TSH level of 0.5-2.0 mU/L

Group Type: ACTIVE_COMPARATOR

Levothyroxine Sodium

Intervention Type: DRUG

Levothyroxine dose will depend on dose at baseline and randomization group

Higher TSH group

Target TSH level of 5.5-7.0 mU/L

Group Type: EXPERIMENTAL

Levothyroxine Sodium

Intervention Type: DRUG

Levothyroxine dose will depend on dose at baseline and randomization group

Interventions

Levothyroxine Sodium

Levothyroxine dose will depend on dose at baseline and randomization group

Intervention Type: DRUG

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Anne Cappola, MD

Professor of Medicine, Division of Endocrinology, Diabetes and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne R. Cappola, M.D., Sc.M.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Penn Medicine, Smilow Translational Research Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anne R. Cappola, M.D., Sc.M.

Role: CONTACT

acappola@pennmedicine.upenn.edu

215-573-5359

Theresa M. Scattergood, M.S.N., R.N.

Role: CONTACT

theresa.scattergood@pennmedicine.upenn.edu

215-898-5664

Other Identifiers

R01AG081698

Identifier Type: NIH

Identifier Source: secondary_id

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1R01AG081698-01

Identifier Type: NIH

Identifier Source: org_study_id

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