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Recently, Zaborek et al. raised a Poisson regression model for levothyroxine(LT4) dosing scheme to predict individual dose of LT4 after thyroidectomy: daily LT4 dose=e[2.02+0.01(W)-0.0037(A )-0.098(F)-0.01(B)+0.007(T)+0.108(I)-0.014(M), where W is the weight of the patient (Kg), A is the age of the patient (years), and F is the gender (for women 1, male is 0), B represents the patient's body mass index (BMI), T represents the preoperative TSH level, I represents whether the patient takes iron preparations (1, if not 0), M represents whether the patient takes multivitamins/minerals (1, if not 0). We demonstrated its value with our retrospective data in our center. Therefore, we intend to carry out this randomized controlled trial in order to further evaluate the model. The clinical significance of this method can provide a basis for the future use in clinical optimization of individualized dosing.](streamdown:incomplete-link)
Patients who underwent total/near-total thyroidectomy or completion thyroidectomy and require levothyroxine replacement therapy will be enrolled in this study. They will be randomized distributed into two groups. In one group, patients will be dosing LT4 according to weight-based algorithm, namely 1.6 μg /kg/d. In the other group, patients will be dosing LT4 according to the Poisson regression model algorithm. They will be followed up 3-6 weeks after surgery for the first time. During the follow up, thyroid hormone will be tested and LT4 dosing will be adjusted accordingly. Then, we compare patients in which group will achieve euthyroidism more quickly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poisson regression model dosing scheme | Experimental | daily levothyroxine dose=e[2.02+0.01(W)-0.0037(A )-0.098(F)-0.01(B)+0.007(T)+0.108(I)-0.014(M), where W is the weight of the patient (Kg), A is the age of the patient (years), and F is the gender (for women 1, male is 0), B represents the patient's body mass index (BMI), T represents the preoperative TSH level, I represents whether the patient takes iron preparations (1, if not 0), M represents whether the patient takes multivitamins/minerals (1, if not 0).](streamdown:incomplete-link) |
|
| weight-based dosing scheme | Active Comparator | daily levothyroxine dose=1.6 μg /kg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levothyroxine Sodium Tablets | Drug | For patients in experimental group, initial levothyroxine dose is calculated through the Poisson regression model; and for patients in comparator group, initial levothyroxine dose is calculated through 1.6 ug/kg/d. |
| Measure | Description | Time Frame |
|---|---|---|
| euthyroidism | a serum thyroid-stimulating hormone (TSH) level of 0.45 - 4.50 mIU/mL | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qunzi Zhao, M.D. | Contact | +86-571-87767101 | qzhao@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qunzi Zhao, M.D. | Second Affiliated Hospital Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30413325 | Background | Zaborek NA, Cheng A, Imbus JR, Long KL, Pitt SC, Sippel RS, Schneider DF. The optimal dosing scheme for levothyroxine after thyroidectomy: A comprehensive comparison and evaluation. Surgery. 2019 Jan;165(1):92-98. doi: 10.1016/j.surg.2018.04.097. Epub 2018 Nov 6. |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D007037 | Hypothyroidism |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D013974 | Thyroxine |
| ID | Term |
|---|---|
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
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|
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |