Endocrine Dysfunction in Pediatric Wilson's Disease

NCT ID: NCT07208565

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-06-30

Study Completion Date

2027-12-30

Brief Summary

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This cross-sectional study investigates endocrine changes in children diagnosed with Wilson's disease, aiming to characterize hormonal dysfunctions affecting pituitary, thyroid, adrenal, and gonadal axes.

Detailed Description

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Wilson's disease (WD) is an inherited copper metabolism disorder leading to copper accumulation in various organs including endocrine glands. While hepatic and neurological effects are well-documented, endocrine manifestations remain insufficiently studied in children. This study will systematically assess hormonal axes-including pituitary, growth hormone, thyroid, adrenal, and gonadal functions-through clinical evaluation, pubertal staging, and biochemical tests. The study aims to measure the prevalence and spectrum of endocrine abnormalities in pediatric WD patients and correlate them with disease severity and therapy. Findings will highlight underrecognized complications that impact growth, puberty, and fertility, contributing to more comprehensive management of WD in children.

Conditions

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Wilson's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pediatric Wilson's Disease Group

All eligible children with Wilson's disease (diagnosed and under treatment or newly diagnosed) evaluated cross-sectionally for endocrine function.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Children aged 3-18 years

Confirmed diagnosis of Wilson's disease (based on clinical features, biochemical markers such as serum ceruloplasmin and 24-hour urinary copper)

Both newly diagnosed and treated patients (chelation/zinc therapy)

Informed consent from parents or guardians

Exclusion Criteria

* Congenital or acquired endocrine disorders unrelated to WD (e.g., congenital hypothyroidism, pituitary tumors)

Concurrent use of medications affecting hormonal function unless prescribed for WD (steroids, thyroid replacements, contraceptives)

Chronic systemic illnesses that confound endocrine assessment (e.g., malignancy, chronic renal failure)
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Atef Ahmed Sayed

resident at the Pediatrics Department, Hepatology Unit, Assiut University Children's Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Kapoor N, Shetty S, Thomas N, Paul TV. Wilson's disease: An endocrine revelation. Indian J Endocrinol Metab. 2014 Nov;18(6):855-7. doi: 10.4103/2230-8210.141383.

Reference Type BACKGROUND
PMID: 25364683 (View on PubMed)

Other Identifiers

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Endocrine Dysfunction

Identifier Type: -

Identifier Source: org_study_id

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