Dosing of LT4 in Older Individuals | NCT06073665

Studies
Dosing of LT4 in Older Individuals

NCT06073665

Sponsor

University of Pennsylvania

Status

Recruiting

Last Update Posted

Feb 19, 2026Actual

Enrollment

228Estimated

Phase

Phase 4

Conditions

Hypothyroidism

Interventions

Levothyroxine Sodium

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AG081698	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2024Actual

Primary Completion Date

Apr 1, 2028Estimated

Completion Date

Apr 1, 2028Estimated

First Submitted Date

Sep 22, 2023

First Submission Date that Met QC Criteria

Oct 2, 2023

First Posted Date

Oct 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2026

Last Update Posted Date

Feb 19, 2026Actual

Name	Class
National Institute on Aging (NIA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

228Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lower TSH Group	Active Comparator	Target TSH level of 0.5-2.0 mU/L	Drug: Levothyroxine Sodium
Higher TSH group	Experimental	Target TSH level of 5.5-7.0 mU/L	Drug: Levothyroxine Sodium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levothyroxine Sodium	Drug	Levothyroxine dose will depend on dose at baseline and randomization group	Higher TSH group Lower TSH Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thyroid-Related Quality of Life Patient-Reported Outcome Quality of Life scale	22 items, scored 0-100, higher scores indicate worse status	6 months

Secondary Outcomes

Measure	Description	Time Frame
Thyroid-Related Quality of Life Patient-Reported Outcome Hypothyroidism subscale b. ThyPRO "Tiredness" subscale c. Thyroid Symptoms Questionnaire (TSQ)	4 items, scored 0-100, higher scores indicate worse status	6 months
NIH Toolbox Fluid Cognition Composite Score

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anne R. Cappola, M.D., Sc.M.	Contact	215-573-5359		acappola@pennmedicine.upenn.edu
Theresa M. Scattergood, M.S.N., R.N.	Contact	215-898-9275		theresa.scattergood@pennmedicine.upenn.edu

Overall Officials

Name	Affiliation	Role
Anne R. Cappola, M.D., Sc.M.	University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Penn Medicine, Smilow Translational Research Center	Recruiting	Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007037	Hypothyroidism

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D013974	Thyroxine

Ancestor Terms

ID	Term
D013963	Thyroid Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D024322	Amino Acids, Aromatic

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Browse Branches

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