NCT06430359 Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
| NCT ID | NCT06430359 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Wilson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2027-02-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-01-10 with a primary completion date of 2027-02-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Wilson's disease (WD) is a genetic disorder characterized by an accumulation of copper in the body, mainly in the liver and brain. Patients suffering from this disease are monitored by liver function tests, blood copper levels, and 24-hour urinary copper determinations. Treatment is based either on chelating the copper accumulated in the body using D-penicillamine or Trientine or on limiting intestinal copper absorption with zinc salts. Monitoring copper elimination in urine collected over 24 hours is essential for estimating a patient's copper load, adapting treatment dosage, and detecting any copper deficiency. Nevertheless, urine collection is often complicated for patients, given the obvious constraints of collecting urine over 24 hours. Without this, clinical decisions are usually made based on spot urine. There is no official recommendation for monitoring urinary copper elimination other than on 24-hour urine. According to studies on healthy volunteers under physiological conditions, urinary copper elimination occurs according to a circadian rhythm, with minimal copper elimination between 8 pm and 4 am and maximum between 8 am and noon. The study would aim to find the period of the day best correlated with 24h urinary copper excretion
Eligibility Criteria
Inclusion Criteria: * Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4). * Age ≥ 6 years and ≤70 years. * Patient able to perform 24h urine. * Current treatment with D-Pencillamine, Trientine or Zinc. * Non-opposition of patient and/or legal representatives for minor patients. Exclusion Criteria: * Patients who had a change in treatment within the last 6 months before the inclusion * Patients who have undergone liver transplantation * Patients with known chronic renal failure (GFR \< 30 ml/min) * Patients on long-term diuretic or corticosteroid therapy * Persons deprived of liberty by a judicial or administrative decision * Patient under judicial protection, unable to express consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06430359 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 70 Years, studying Wilson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06430359 currently recruiting?
Yes, NCT06430359 is actively recruiting participants. Contact the research team at eduardo.couchonnal-bedoya@chu-lyon.fr for enrollment information.
Where is the NCT06430359 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT06430359 clinical trial?
NCT06430359 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 30 participants.