Thyroid Disorders in Pediatric Autoimmune Hepatitis

NCT07827235 | Not Yet Recruiting

• 1 other identifier: Thyroid-AIH-Assiut-2026
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autoimmune Hepatitis; Graves Disease; Thyroid Disease; Hashimoto Thyroiditis

Keywords

Autoimmune hepatitis; Thyroid disorders; Anti-TPO; Pediatric; Assiut

Outcome Measures

Primary Outcomes (1)

• Frequency of thyroid disorders

  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

  Baseline

Secondary Outcomes (6)

• Pattern of thyroid disorders

  Baseline

• Thyroid autoantibody positivity

  Baseline

• Thyroid ultrasonographic abnormalities

  Baseline

• Serum TSH level

  Baseline

• Serum free T4 level

  Baseline

Study Arms (1)

Single cohort: Children with autoimmune hepatitis

Children less than 18 years with autoimmune hepatitis who will undergo thyroid function tests, thyroid autoantibodies, and thyroid ultrasonography.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children less than 18 years diagnosed with autoimmune hepatitis attending the Pediatric Hepatology Unit and Outpatient Clinic at Assiut University Children's Hospital.

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Mieli-Vergani G, Vergani D, Baumann U, Czubkowski P, Debray D, Dezsofi A, Fischler B, Gupte G, Hierro L, Indolfi G, Jahnel J, Smets F, Verkade HJ, Hadzic N. Diagnosis and Management of Pediatric Autoimmune Liver Disease: ESPGHAN Hepatology Committee Position Statement. J Pediatr Gastroenterol Nutr. 2018 Feb;66(2):345-360. doi: 10.1097/MPG.0000000000001801.

  PMID: 29356770 BACKGROUND

• Ijaz MK, Sattar SA, Boone SA, Nims RW, McKinney J, Gerba CP. Dynamics of respiratory virus spread indoors suggest a holistic approach for exposure risk mitigation. Antimicrob Steward Healthc Epidemiol. 2025 Oct 29;5(1):e289. doi: 10.1017/ash.2025.10147. eCollection 2025.

  PMID: 41180295 BACKGROUND

• Chen M, Gu H, Xuan G, Ma L, Tu S, Li M. Elective neck dissection versus elective neck irradiation in cT3/4N0 maxillary sinus squamous cell carcinoma: a propensity score matching analysis. World J Surg Oncol. 2024 Apr 15;22(1):95. doi: 10.1186/s12957-024-03368-8.

  PMID: 38622695 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases; Hepatitis, Autoimmune; Hashimoto Disease; Graves Disease

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Thyroiditis, Autoimmune; Thyroiditis; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Hyperthyroidism

Study Officials

• Amal A seliman, prof

  pediatrics Department, Assiut University Hospitals

  STUDY CHAIR

• Shereen M Galal, Prof

  pediatrics Department, Assiut University Hospitals

  STUDY CHAIR

Central Study Contacts

Arwa M Mohamed, Resident

CONTACT

+20 10 26065202; Arwa.18313343@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Pediatrics

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): September 25, 2027
• Study Completion (Estimated): February 10, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09