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.
.Participants will * Take LT4+LT3 or LT4+placebo for 6 months * Visit the clinic at the beginning and the end of the study for a blood test and to answer questionnaires. * Have blood tests checked at 6 and 13 weeks and symptom checks by text (weekly to monthly)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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.
All participants will take levothyroxine.
Identical placebo tablet without containing liothyronine
Penn Medicine, Smilow Center for Translational Resarch,
Philadelphia, Pennsylvania, United States
ThyPRO Composite QOL Scale
22 items, scored 0-100, higher scores indicate worse status
Time frame: 6 months
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
Beck Anxiety Inventory
21 items, range 0-63, higher scores indicate more anxiety
Time frame: Baseline and 6 months
Pittsburgh Sleep Quality Index
19 items, range of 0-21, higher scores indicate worse sleep
Time frame: 6 months
Weight
Kilograms
Time frame: 6 months
LDL cholesterol
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Blood test, g/dL
Time frame: 6 months
Serum c-telopeptide
Blood test, pg/mL
Time frame: 6 months
Satisfaction with randomized status
Participants will be asked if they can guess their randomization status and satisfaction with randomized status
Time frame: 6 months