Individual Dosing of Levothyroxine After Thyroidectomy

NCT05240911 | Unknown

• 1 other identifier: 2019-041
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Neoplasms; Hypothyroidism; Surgery

Keywords

levothyroxine; thyroidectomy; thyroid hormone replacement therapy; individualized therapy; regression model

Outcome Measures

Primary Outcomes (1)

• euthyroidism

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

  1 year

Study Arms (2)

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).

Drug: Levothyroxine Sodium Tablets

weight-based dosing scheme

ACTIVE COMPARATOR

daily levothyroxine dose=1.6 μg /kg/d

Drug: Levothyroxine Sodium Tablets

Interventions

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.

Also known as: LT4

Poisson regression model dosing scheme; weight-based dosing scheme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• patients with heart disease or severe liver/kidney insufficiency; patients taking liothyronine in addition to levothyroxine;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 30413325 BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms; Hypothyroidism

Interventions

Thyroxine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Qunzi Zhao, M.D.

  Second Affiliated Hospital Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qunzi Zhao, M.D.

CONTACT

+86-571-87767101; qzhao@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: February 15, 2022
• Study Start: June 1, 2022
• Primary Completion: February 10, 2023
• Study Completion: June 10, 2023
• Last Updated: May 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)