Surgery Clinical Trial
Official title:
Compare a New Method to the Traditional One to Estimate Levothyroxine Dose for Patients Needing Replacement Therapy After Total or Completion Thyroidectomy
NCT number | NCT05240911 |
Other study ID # | 2019-041 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | June 10, 2023 |
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.
Status | Recruiting |
Enrollment | 202 |
Est. completion date | June 10, 2023 |
Est. primary completion date | February 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients underwent total/near-total thyroidectomy or completion thyroidectomy; patients with benign disease, or low-risk differentiated thyroid cancer, or medullary thyroid cancer who don't need TSH suppressive therapy; Exclusion Criteria: - patients with heart disease or severe liver/kidney insufficiency; patients taking liothyronine in addition to levothyroxine; |
Country | Name | City | State |
---|---|---|---|
China | Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
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. Erratum in: Surgery. 2022 Apr 25;:. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | euthyroidism | a serum thyroid-stimulating hormone (TSH) level of 0.45 - 4.50 mIU/mL | 1 year |
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