ClinicalTrials.gg
RecruitingNCT06570967Updated Aug 27, 2024

A Clinical Study of Hyperthyroidism in Children

An observational study in Hyperthyroidism, sponsored by Shengjing Hospital. Recruiting at 1 site in China. Open to participants aged 29 Days to 14 Years. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Shengjing Hospital · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000
Ages
29 Days to 14 Years
Sex
All
01

Study summary

This study intends to conduct a retrospective and prospective study on children with hyperthyroidism, and it is a non-intervention study to collect information on diagnosis and treatment and long-term follow-up of children with hyperthyroidism. To investigate the clinical characteristics, treatment effect, side effects and remission of hyperthyroidism in children, to analyze the predictive factors for the effect of antithyroid drug treatment, remission and recurrence after drug withdrawal, and to explore the risk factors related to the occurrence of antithyroid drug-related adverse reactions.

02

Conditions studied

  • Hyperthyroidism

Browse trials for

03

In context

Hyperthyroidism

112 studies on the registry are indexed under Hyperthyroidism; 27 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 98 across 48 observational studies indexed under Hyperthyroidism.

Browse Hyperthyroidism studies →

Lead sponsor

Shengjing Hospital is the lead sponsor of 127 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Days to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population included male and female with hyperthyroidism aged no more than 14 years. Participants must have not been treated with medication in other hospitals, have no history of autoimmune hepatitis, viral hepatitis, hematological diseases, bone marrow or liver transplantation, and have complete clinical data.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≤14 years old
  2. Initial diagnosis of hyperthyroidism

Exclusion criteria

Exclusion Criteria:

  1. Hyperthyroidism had been treated with medication in other hospitals,
  2. History of hepatitis, viral hepatitis, hematological diseases, bone marrow or liver transplantation,
  3. Patients with incomplete clinical data
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Interventions

  • The initial dose of methimazole was 0.2-0.8 mg/(kg▪d). This dose was subsequently reduced by 25% to 50% and adjusted to maintain euthyroidism, based on the results of serum thyroid hormone testing during follow-up.

06

What researchers measure

Primary outcomes

  1. Remission of hyperthyroidism in children treated with methimazole. Remission is defined as having clinical and biochemical euthyroidism(FT3, FT4 and TSH are normal) without methimazole treatment for at least 12 months.

    To analyze the therapeutic effect of methimazole and the predictors of remission of hyperthyroidism after methimazole treatment.

    Time frame: 10 years

  2. Adverse effects of methimazole in the treatment of hyperthyroidism in children. Adverse effects are defined as having neutropenia (absolute neutrophil count< 1500/µL), liver dysfunction (AST or ALT> 60 IU/L), rash, arthralgia, myalgia, et al.

    Analyze the adverse reaction of methimazole treatment in hyperthyroidism children. Explore the risk factors related to the occurrence of methimazole related adverse reactions.

    Time frame: 1 year

Secondary outcomes

  1. Relapse of hyperthyroidism in children treated with methimazole. Relapse was defined as having clinical and biochemical hyperthyroidism (FT3 and FT4 increased and TSH decreased) after discontinuation of methimazole.

    The risk factors of relapse in children with hyperthyroidism treated with MMI were analyzed

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2023 (actual). Primary completion is estimated for Dec 2026, 41 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2024
First posted
Aug 26, 2024
StartActual
Jul 18, 2023
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2027
Last update
Aug 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06570967
Lead sponsor
Shengjing Hospital
Responsible party
Shi Tang (Attending Physician, Shengjing Hospital) — Principal investigator
First posted
Aug 26, 2024
Start date
Jul 18, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 27, 2024

Study contacts

Shi Tang, Doctor
Contact
ts047827@163.com
+8618940259064

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion