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Not yet recruiting NCT07208565

Endocrine Dysfunction in Pediatric Wilson's Disease

Observational Wilson's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Wilson's Disease. Basic parameters: 3 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Cross-sectional Study of Endocrine Changes in Children With Wilson's Disease at Assiut University Children's Hospital

Overview

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

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.

Primary outcome measures

  • prevalence of endocrine dysfunction in pediatric Wilson's disease [Time frame: baseline]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 25364683

Identifiers

NCT: NCT07208565 · Endocrine Dysfunction

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗