Individual Dosing of Levothyroxine After Thyroidectomy

Not Applicable

• Conditions: Thyroid Neoplasms; Hypothyroidism; Surgery
• Interventions: Drug: Levothyroxine Sodium Tablets

• Registration Number: NCT05240911
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-02-06
• Study First Submitted QC: 2022-02-06
• Study First Posted: 2022-02-15
• Last Update Submitted: 2022-05-08
• Last Update Posted: 2022-05-10
• Study Start: 2022-06-01
• Primary Completion: 2023-02-10
• Study Completion: 2023-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 202

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Poisson regression model dosing scheme	Levothyroxine Sodium Tablets	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).
weight-based dosing scheme	Levothyroxine Sodium Tablets	daily levothyroxine dose=1.6 μg /kg/d

Primary Outcome Measures

Name	Time	Method
euthyroidism	1 year	a serum thyroid-stimulating hormone (TSH) level of 0.45 - 4.50 mIU/mL

Trial Locations

Locations (1)

Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China