Thyroid Disorders in Pediatric Autoimmune Hepatitis
September 14, 2026 updated by: Arwa Alaaeldin Mohamed Ahmed, Assiut University
Frequency of Thyroid Disorders in Pediatric Patients With Autoimmune Hepatitis at Assiut University Children's Hospital
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.
Study Overview
Status
Not yet recruiting
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arwa M Mohamed, Resident
- Phone Number: +20 10 26065202
- Email: Arwa.18313343@med.aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
|
Thyroid autoantibody positivity
Time Frame: Baseline
|
Number of participants with positive anti-thyroid peroxidase and/or anti-thyroglobulin antibodies
|
Baseline
|
|
Thyroid ultrasonographic abnormalities
Time Frame: Baseline
|
Proportion of children with abnormal thyroid ultrasound findings (enlargement, hypoechogenicity, nodules, or altered vascularity).
|
Baseline
|
|
Serum TSH level
Time Frame: Baseline
|
Mean serum thyroid-stimulating hormone (TSH) level (µIU/mL).
|
Baseline
|
|
Serum free T4 level
Time Frame: Baseline
|
Mean serum free thyroxine (FT4) level (ng/dL).
|
Baseline
|
|
Serum free T3 level
Time Frame: Baseline
|
Mean serum free triiodothyronine (FT3) level (pg/mL).
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Amal A seliman, prof, Pediatrics Department, Assiut University Hospitals
- Study Chair: Shereen M Galal, Prof, Pediatrics Department, Assiut University Hospitals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
September 25, 2027
Study Completion (Estimated)
February 10, 2028
Study Registration Dates
First Submitted
September 14, 2026
First Submitted That Met QC Criteria
September 14, 2026
First Posted (Actual)
September 18, 2026
Study Record Updates
Last Update Posted (Actual)
September 18, 2026
Last Update Submitted That Met QC Criteria
September 14, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Autoimmune Diseases
- Immune System Diseases
- Digestive System Diseases
- Eye Diseases
- Liver Diseases
- Exophthalmos
- Orbital Diseases
- Goiter
- Hyperthyroidism
- Hepatitis, Chronic
- Hepatitis
- Thyroiditis, Autoimmune
- Thyroiditis
- Thyroid Diseases
- Graves Disease
- Hashimoto Disease
- Hepatitis, Autoimmune
Other Study ID Numbers
- Thyroid-AIH-Assiut-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.