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NCT Number: NCT06570967

A Clinical Study of Hyperthyroidism in Children

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.

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Key information

Conditions

Hyperthyroidism Endocrine System Diseases Thyroid Diseases

Age range

29 day–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location status: Recruiting

Location contact

Ying Xin, Doctor

CONTACT

[email protected]

+8618940251876

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≤14 years old
  • Initial diagnosis of hyperthyroidism

Exclusion criteria

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

Treatment and study plan

Methimazole(MMI)

Drug

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.

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.

    Time frame: 10 years

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

  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.

    Time frame: 1 year

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

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.

    Time frame: 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Shi Tang, Doctor

CONTACT

[email protected]

+8618940259064

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

A Retrospective and Prospective Observational Study of Hyperthyroidism in Children

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 26, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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