T4/T3 Therapy in Hypothyroidism

ConditionHypothyroidism Primary

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorUniversity of Pennsylvania

About this trial

This study will test whether 6 months of combination therapy with levothyroxine (LT4) plus liothyronine (LT3) is superior to LT4 plus placebo in participants with hypothyroidism who have residual symptoms of hypothyroidism with TSH levels within the reference range.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged 18-70 years

Hypothyroidism due to either thyroid failure or total thyroidectomy for structural thyroid disease (nodules, benign goiter, or thyroid cancer) for at least 6 months

Taking 75-150 mcg per day LT4 and a minimum of 1.2 mcg/kg/day, with stable dose of LT4 for at least 3 months prior to enrollment

TSH of 0.5 to 4.0 mU/L within 2 months of enrollment

Disqualifiers

Current use of LT3, thyroid extracts, Tirosint liquid or capsules, amiodarone, lithium, methimazole, propylthiouracil, supraphysiologic doses of corticosteroids, immunotherapy, tyrosine kinase inhibitors, interferon, or biotin supplements

Diseases of the pituitary or hypothalamus

History of thyroid cancer requiring suppression of TSH secretion

Unstable cardiac conditions, including uncontrolled hypertension (current blood pressure greater than 160/100), arrhythmia, or angina

Trial design

Design model

Parallel

Treatments tested in this trial

Liothyronine (L-T3)
Drug
Participants will either take LT3 with an LT4 dose that is reduced from baseline or they will take liothyronine placebo with their baseline LT4 dose.
Levothyroxine Sodium (LT4) Tablets
Drug
All participants will take levothyroxine.
Liothyronine (LT3) placebo
Drug
Identical placebo tablet without containing liothyronine

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: LT4+LT3Experimental treatment 2 interventions

Group B: LT4+placeboActive comparator 2 interventions

Trial outcomes

Primary outcomes

ThyPRO Composite QOL Scale

22 items, scored 0-100, higher scores indicate worse status

Time frame

6 months

Secondary outcomes

ThyPRO subscales

ThyPRO hypothyroid symptoms and tiredness subscales, 4 items, scored 0-100, higher scores indicate worse status

Time frame

6 months

Thyroid Symptoms Questionnaire (TSQ)

Thyroid symptoms scale, 12 items, score range 0-36, higher score indicates worse status

Time frame

6 months

Cognitive measures

NIH Toolbox Fluid Cognition Score, based around median of 100, higher scores indicate higher function

Time frame

Baseline and 6 months

Beck Depression Inventory

21 items, range of 0-63, higher scores indicate more depressive symptoms

Time frame

Baseline and 6 months

Other outcomes

Symptom checks

Questionnaire of 4 hypothyroid symptoms, higher scores indicate worse function

Time frame

Weekly for 8 weeks and at months 3, 4, and 5

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

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