Thyroid Disorders in Pediatric Autoimmune Hepatitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
- 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)
Trial population
Children less than 18 years diagnosed with autoimmune hepatitis attending the Pediatric Hepatology Unit and Outpatient Clinic at Assiut University Children's Hospital.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
32 Participants
are grouped into 1 trial groupGroup A: Single cohort: Children with autoimmune hepatitis
Trial outcomes
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
Time frame
BaselineSecondary outcomes
1
Pattern of thyroid disorders
Number of participants with specific thyroid disorders including Hashimoto thyroiditis, Graves disease, subclinical hypothyroidism, subclinical hyperthyroidism, and others
Time frame
Baseline2
Thyroid autoantibody positivity
Number of participants with positive anti-thyroid peroxidase and/or anti-thyroglobulin antibodies
Time frame
Baseline3
Thyroid ultrasonographic abnormalities
Proportion of children with abnormal thyroid ultrasound findings (enlargement, hypoechogenicity, nodules, or altered vascularity).
Time frame
Baseline4
Serum TSH level
Mean serum thyroid-stimulating hormone (TSH) level (µIU/mL).
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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