NCT06073665

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for phase_4

Timeline
23mo left

Started Jan 2024

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jan 2024Apr 2028

First Submitted

Initial submission to the registry

September 22, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

September 22, 2023

Last Update Submit

February 17, 2026

Conditions

Hypothyroidism

Keywords

Levothyroxine Dosing

Outcome Measures

Primary Outcomes (1)

  • 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 (9)

  • Thyroid-Related Quality of Life Patient-Reported Outcome Hypothyroidism subscale b. ThyPRO "Tiredness" subscale c. Thyroid Symptoms Questionnaire (TSQ)

    6 months

  • NIH Toolbox Fluid Cognition Composite Score

    6 months

  • Geriatric Depression Scale

    6 months

  • Pittsburgh Sleep Quality Index

    6 months

  • Weight

    6 months

  • +4 more secondary outcomes

Study Arms (2)

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

Levothyroxine SodiumDRUG

Levothyroxine dose will depend on dose at baseline and randomization group

Higher TSH groupLower TSH Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Medicine, Smilow Translational Research Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Anne R. Cappola, M.D., Sc.M.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

215-573-5359acappola@pennmedicine.upenn.edu

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

CONTACT

215-898-9275theresa.scattergood@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
overencapsulated levothyroxine doses will be provided by the investigational drug pharmacy
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, parallel, double-blind clinical trial of two 6-month dosing strategies of levothyroxine (LT4)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Division of Endocrinology, Diabetes and Metabolism

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 10, 2023

Study Start

January 31, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)