Wilson's DiseaseNCT07208565
Endocrine Dysfunction in Pediatric Wilson's Disease
An observational study of Wilson's Disease, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Wilson's Disease
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All eligible children with Wilson's disease (diagnosed and under treatment or newly diagnosed) evaluated cross-sectionally for endocrine function.
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: A Cross-sectional Study of Endocrine Changes in Children With Wilson's Disease at Assiut University Children's Hospital
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.
Read the 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.
- Conditions
- Wilson's Disease
- Keywords
- Wilson's
- Medical subject headings
- Hepatolenticular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start30 Jun 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wilson's DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Atef Ahmed Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208565
- Sponsor's protocol ID
- Endocrine Dysfunction
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 25364683
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of Endocrine Changes in Children With Wilson's Disease at Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT07208565
- Acronym / sponsor ID
- Endocrine Dysfunction
- Conditions
- Wilson's Disease
- Keywords
- Wilson's
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All eligible children with Wilson's disease (diagnosed and under treatment or newly diagnosed) evaluated cross-sectionally for endocrine function.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of endocrine dysfunction in pediatric Wilson's disease
Time frame: baseline
Identification and classification of hormonal abnormalities affecting pituitary, adrenal, thyroid, and gonadal axes at study enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Background: PubMed 25364683Kapoor 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.
Related trials for Wilson's Disease
RecruitingPhase 3
Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.
Wilson's Disease
RecruitingObservational study
Oral Health and Wilson's Disease: SOMAWI
Wilson Disease
Recruiting
Cardiac Involvement in Wilson's Disease
Wilson's Disease
Recruiting
Description of the Copper Concentration in Breast Milk in Women Treated for Wilson's Disease
Wilson's Disease
RecruitingPhase 1/2
A Study of the Safety and Efficacy of Prime Editing (PM577) in Participants With Wilson Disease (WD)
Wilson Disease, Wilson's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Wilson's Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of endocrine dysfunction in pediatric Wilson's disease (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07208565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.