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A Clinical Study of Hyperthyroidism in Children

A Retrospective and Prospective Observational Study of Hyperthyroidism in Children

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06570967
Enrollment
1000
Registered
2024-08-26
Start date
2023-07-18
Completion date
2027-12-31
Last updated
2024-08-27

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

Conditions

Hyperthyroidism

Brief 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.

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.

Sponsors

Shengjing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
29 Days to 14 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. Hyperthyroidism had been treated with medication in other hospitals, 2. History of autoimmune hepatitis, viral hepatitis, hematological diseases, bone marrow or liver transplantation, 3. Patients with incomplete clinical data

Design outcomes

Primary

MeasureTime frameDescription
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.10 yearsTo analyze the therapeutic effect of methimazole and the predictors of remission of hyperthyroidism after methimazole treatment.
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.1 yearAnalyze the adverse reaction of methimazole treatment in hyperthyroidism children. Explore the risk factors related to the occurrence of methimazole related adverse reactions.

Secondary

MeasureTime frameDescription
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.10 yearsThe risk factors of relapse in children with hyperthyroidism treated with MMI were analyzed

Countries

China

Contacts

Primary ContactShi Tang, Doctor
ts047827@163.com+8618940259064

Outcome results

None listed

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