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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK137207 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LT4+LT3 | Experimental | Levothyroxine plus liothyronine therapy |
|
| LT4+placebo | Active Comparator | Levothyroxine plus liothyronine placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ThyPRO Composite QOL Scale | 22 items, scored 0-100, higher scores indicate worse status | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ThyPRO subscales | ThyPRO hypothyroid symptoms and tiredness subscales, 4 items, scored 0-100, higher scores indicate worse status | 6 months |
| Thyroid Symptoms Questionnaire (TSQ) | Thyroid symptoms scale, 12 items, score range 0-36, higher score indicates worse status |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom checks | Questionnaire of 4 hypothyroid symptoms, higher scores indicate worse function | Weekly for 8 weeks and at months 3, 4, and 5 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne R. Cappola, MD, ScM | Contact | 215-573-5359 | acappola@pennmedicine.upenn.edu | |
| Theresa Scattergood, MSN, RN | Contact | 215-898-5664 | theresa.scattergood@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine, Smilow Center for Translational Resarch, | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014284 | Triiodothyronine |
| D013974 | Thyroxine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D013970 | Thyronines |
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Levothyroxine Sodium (LT4) Tablets | Drug | All participants will take levothyroxine. |
|
| Liothyronine (LT3) placebo | Drug | Identical placebo tablet without containing liothyronine |
|
| 6 months |
| Cognitive measures | NIH Toolbox Fluid Cognition Score, based around median of 100, higher scores indicate higher function | Baseline and 6 months |
| Beck Depression Inventory | 21 items, range of 0-63, higher scores indicate more depressive symptoms | Baseline and 6 months |
| Beck Anxiety Inventory | 21 items, range 0-63, higher scores indicate more anxiety | Baseline and 6 months |
| Pittsburgh Sleep Quality Index | 19 items, range of 0-21, higher scores indicate worse sleep | 6 months |
| Weight | Kilograms | 6 months |
| LDL cholesterol | Blood test, g/dL | 6 months |
| Serum c-telopeptide | Blood test, pg/mL | 6 months |
| Satisfaction with randomized status | Participants will be asked if they can guess their randomization status and satisfaction with randomized status | 6 months |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |