Hypothyroidism Primary
Conditions
Keywords
Hypothyroidism, levothyroxine, liothyronine
Brief summary
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.
Detailed description
.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)
Interventions
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.
DRUGLiothyronine (LT3) placebo
Identical placebo tablet without containing liothyronine
Sponsors
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged 18-70 years 2. Hypothyroidism due to either thyroid failure or total thyroidectomy for structural thyroid disease (nodules, benign goiter, or thyroid cancer) for at least 6 months 3. 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 4. TSH of 0.5 to 4.0 mU/L within 2 months of enrollment 5. Persistent symptoms for at least 2 months, and a TSQ score of ≥ 5 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study intervention.
Exclusion criteria
1. 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 2. Diseases of the pituitary or hypothalamus 3. History of thyroid cancer requiring suppression of TSH secretion 4. Unstable cardiac conditions, including uncontrolled hypertension (current blood pressure greater than 160/100), arrhythmia, or angina 5. Uncontrolled psychiatric disorders 6. Pregnancy or lactation, or planned pregnancy within the next 7 months 7. History of food dye allergies 8. GFR \<30 ml/min/1.73 m2 9. Other conditions which, in the opinion of the investigators, would prevent them from participating in the full duration of the study (for example, end-stage cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ThyPRO Composite QOL Scale | 6 months | 22 items, scored 0-100, higher scores indicate worse status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ThyPRO subscales | 6 months | ThyPRO hypothyroid symptoms and tiredness subscales, 4 items, scored 0-100, higher scores indicate worse status |
| Thyroid Symptoms Questionnaire (TSQ) | 6 months | Thyroid symptoms scale, 12 items, score range 0-36, higher score indicates worse status |
| Cognitive measures | Baseline and 6 months | NIH Toolbox Fluid Cognition Score, based around median of 100, higher scores indicate higher function |
| Beck Depression Inventory | Baseline and 6 months | 21 items, range of 0-63, higher scores indicate more depressive symptoms |
| Beck Anxiety Inventory | Baseline and 6 months | 21 items, range 0-63, higher scores indicate more anxiety |
| Pittsburgh Sleep Quality Index | 6 months | 19 items, range of 0-21, higher scores indicate worse sleep |
| Weight | 6 months | Kilograms |
| LDL cholesterol | 6 months | Blood test, g/dL |
| Serum c-telopeptide | 6 months | Blood test, pg/mL |
| Satisfaction with randomized status | 6 months | Participants will be asked if they can guess their randomization status and satisfaction with randomized status |
Countries
United States
Contacts
CONTACTAnne R. Cappola, MD, ScM
CONTACTTheresa Scattergood, MSN, RN
Outcome results
None listed