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Individual Dosing of Levothyroxine After Thyroidectomy

Primary Purpose

Thyroid Neoplasms, Hypothyroidism, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Levothyroxine Sodium Tablets
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Neoplasms focused on measuring levothyroxine, thyroidectomy, thyroid hormone replacement therapy, individualized therapy, regression model

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Second Affiliated Hospital Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Poisson regression model dosing scheme

weight-based dosing scheme

Arm Description

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).

daily levothyroxine dose=1.6 μg /kg/d

Outcomes

Primary Outcome Measures

euthyroidism
a serum thyroid-stimulating hormone (TSH) level of 0.45 - 4.50 mIU/mL

Secondary Outcome Measures

Full Information

First Posted
February 6, 2022
Last Updated
May 8, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05240911
Brief Title
Individual Dosing of Levothyroxine After Thyroidectomy
Official Title
Compare a New Method to the Traditional One to Estimate Levothyroxine Dose for Patients Needing Replacement Therapy After Total or Completion Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
February 10, 2023 (Anticipated)
Study Completion Date
June 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasms, Hypothyroidism, Surgery
Keywords
levothyroxine, thyroidectomy, thyroid hormone replacement therapy, individualized therapy, regression model

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Poisson regression model dosing scheme
Arm Type
Experimental
Arm Description
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).
Arm Title
weight-based dosing scheme
Arm Type
Active Comparator
Arm Description
daily levothyroxine dose=1.6 μg /kg/d
Intervention Type
Drug
Intervention Name(s)
Levothyroxine Sodium Tablets
Other Intervention Name(s)
LT4
Intervention Description
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.
Primary Outcome Measure Information:
Title
euthyroidism
Description
a serum thyroid-stimulating hormone (TSH) level of 0.45 - 4.50 mIU/mL
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qunzi Zhao, M.D.
Phone
+86-571-87767101
Email
qzhao@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qunzi Zhao, M.D.
Organizational Affiliation
Second Affiliated Hospital Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qunzi Zhao, M.D.
Phone
+86-571-87767101
Email
qzhao@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Zhiyu Li, MD
First Name & Middle Initial & Last Name & Degree
Hengqing Zhu, MD
First Name & Middle Initial & Last Name & Degree
Yukai Chen, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30413325
Citation
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 Jul;172(1):477.
Results Reference
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Individual Dosing of Levothyroxine After Thyroidectomy

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