Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07827235

Thyroid Disorders in Pediatric Autoimmune Hepatitis

This cross-sectional study aims to determine the frequency and spectrum of thyroid disorders among children with autoimmune hepatitis attending Assiut University Children's Hospital.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Thyroid Disease Autoimmune Diseases Autoimmune Hepatitis Digestive System Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Hashimoto Disease Hashimoto Thyroiditis Hepatitis Hepatitis, Autoimmune Hepatitis, Chronic Hyperthyroidism Immune System Diseases Liver Diseases Orbital Diseases Thyroid Diseases Thyroiditis Thyroiditis, Autoimmune

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

About this study

Autoimmune hepatitis is frequently associated with other autoimmune disorders, particularly autoimmune thyroid diseases. Thyroid dysfunction in children may remain asymptomatic yet affect growth and development.

This observational study will include children less than 18 years diagnosed with autoimmune hepatitis according to the Revised International Autoimmune Hepatitis Group (IAIHG) scoring system. All participants will undergo thyroid function tests (TSH, FT3, FT4), thyroid autoantibodies (anti-TPO, anti-Tg), and thyroid ultrasonography.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age less than 18 years
  • Diagnosis of autoimmune hepatitis according to the Revised International Autoimmune Hepatitis Group (IAIHG) scoring system
  • Written informed consent from parents or legal guardians

Exclusion criteria

  • - Previously diagnosed thyroid disorders before the diagnosis of autoimmune hepatitis
  • Medications known to interfere with thyroid function tests (other than corticosteroids or immunosuppressive therapy for AIH)
  • Chronic systemic diseases known to affect thyroid function independently of AIH
  • Other autoimmune disorders (celiac disease, diabetes, inflammatory bowel disease)
  • Refusal to participate

Treatment and study plan

Primary outcomes

  1. Frequency of thyroid disorders

    Time frame: Baseline

    Number of participants with autoimmune hepatitis who have any thyroid disorder including overt or subclinical hypothyroidism, hyperthyroidism, or autoimmune thyroiditis based on thyroid function tests, autoantibodies, and ultrasonography

Secondary outcomes

  1. Pattern of thyroid disorders

    Time frame: Baseline

    Number of participants with specific thyroid disorders including Hashimoto thyroiditis, Graves disease, subclinical hypothyroidism, subclinical hyperthyroidism, and others

  2. Thyroid autoantibody positivity

    Time frame: Baseline

    Number of participants with positive anti-thyroid peroxidase and/or anti-thyroglobulin antibodies

  3. Thyroid ultrasonographic abnormalities

    Time frame: Baseline

    Proportion of children with abnormal thyroid ultrasound findings (enlargement, hypoechogenicity, nodules, or altered vascularity).

  4. Serum TSH level

    Time frame: Baseline

    Mean serum thyroid-stimulating hormone (TSH) level (µIU/mL).

  5. Serum free T4 level

    Time frame: Baseline

    Mean serum free thyroxine (FT4) level (ng/dL).

  6. Serum free T3 level

    Time frame: Baseline

    Mean serum free triiodothyronine (FT3) level (pg/mL).

Study contacts

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

Arwa M Mohamed, Resident

CONTACT

[email protected]

+20 10 26065202

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Frequency of Thyroid Disorders in Pediatric Patients With Autoimmune Hepatitis at Assiut University Children's Hospital

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.