Skip to content

Individual Dosing of Levothyroxine After Thyroidectomy

Compare a New Method to the Traditional One to Estimate Levothyroxine Dose for Patients Needing Replacement Therapy After Total or Completion Thyroidectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05240911
Enrollment
202
Registered
2022-02-15
Start date
2022-06-01
Completion date
2023-06-10
Last updated
2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism, Surgery, Thyroid Neoplasms

Keywords

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

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.

Interventions

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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
euthyroidism1 yeara serum thyroid-stimulating hormone (TSH) level of 0.45 - 4.50 mIU/mL

Countries

China

Contacts

Primary ContactQunzi Zhao, M.D.
qzhao@zju.edu.cn+86-571-87767101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026