Thyroid NeoplasmsNCT05240911
Individual Dosing of Levothyroxine After Thyroidectomy
A study testing Levothyroxine Sodium Tablets in people with Thyroid Neoplasms and Hypothyroidism, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Neoplasms, Hypothyroidism, Surgery
- What is being tested?
- Levothyroxine Sodium Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 10 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- patients with heart disease or severe liver/kidney insufficiency; patients taking liothyronine in addition to levothyroxine;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Qunzi Zhao, M.D., +86-571-87767101, qzhao@zju.edu.cn
Zhiyu Li, MD
About this study
Official title: Compare a New Method to the Traditional One to Estimate Levothyroxine Dose for Patients Needing Replacement Therapy After Total or Completion Thyroidectomy
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.
Read the 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.
- Conditions
- Thyroid Neoplasms, Hypothyroidism, Surgery
- Being tested
- Levothyroxine Sodium Tablets
- Keywords
- levothyroxine, thyroidectomy, thyroid hormone replacement therapy, individualized therapy, regression model
- Medical subject headings
- Thyroid Neoplasms, Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levothyroxine Sodium TabletsDrug
Also called LT4
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Levothyroxine Sodium Tablets |
| weight-based dosing scheme | Active comparator | daily levothyroxine dose=1.6 μg /kg/d Receives: Drug: Levothyroxine Sodium Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
euthyroidism
a serum thyroid-stimulating hormone (TSH) level of 0.45 - 4.50 mIU/mL
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Jun 2022 (estimated)
- Primary completion10 Feb 2023 (estimated)
- Study completion10 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qunzi Zhao, M.D., Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240911
- Sponsor's protocol ID
- 2019-041
- Status last verified
- Jan 2022
- First submitted
- 6 Feb 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30413325
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare a New Method to the Traditional One to Estimate Levothyroxine Dose for Patients Needing Replacement Therapy After Total or Completion Thyroidectomy
- ClinicalTrials.gov ID
- NCT05240911
- Acronym / sponsor ID
- 2019-041
- Conditions
- Thyroid Neoplasms, Hypothyroidism, Surgery
- Keywords
- levothyroxine, thyroidectomy, thyroid hormone replacement therapy, individualized therapy, regression model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 10 Feb 2023 (estimated)
- Study completion
- 10 Jun 2023 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poisson regression model dosing scheme | Experimental | Drug: Levothyroxine Sodium Tabletsdaily 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 | Active comparator | Drug: Levothyroxine Sodium Tabletsdaily levothyroxine dose=1.6 μg /kg/d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (1 listed)
- patients with heart disease or severe liver/kidney insufficiency; patients taking liothyronine in addition to levothyroxine;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levothyroxine Sodium TabletsAlso: LT4For 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. | Drug | Poisson regression model dosing scheme, weight-based dosing scheme |
Primary outcome
euthyroidism
Time frame: 1 year
a serum thyroid-stimulating hormone (TSH) level of 0.45 - 4.50 mIU/mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Background: PubMed 30413325Zaborek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qunzi Zhao, M.D. principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levothyroxine Sodium Tablets in people with Thyroid Neoplasms and Hypothyroidism, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qunzi Zhao, M.D. (+86-571-87767101, qzhao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
euthyroidism (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05240911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.