NCT07208565

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
18mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

June 30, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

September 28, 2025

Last Update Submit

September 28, 2025

Conditions

Keywords

Wilson's

Outcome Measures

Primary Outcomes (1)

  • prevalence of endocrine dysfunction in pediatric Wilson's disease

    Identification and classification of hormonal abnormalities affecting pituitary, adrenal, thyroid, and gonadal axes at study enrollment

    baseline

Study Arms (1)

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.

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 25364683BACKGROUND

MeSH Terms

Conditions

Hepatolenticular Degeneration

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolism, Inborn ErrorsMetal Metabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at the Pediatrics Department, Hepatology Unit, Assiut University Children's Hospital

Study Record Dates

First Submitted

September 28, 2025

First Posted

October 6, 2025

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

October 6, 2025

Record last verified: 2025-09