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Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients

Recruitingn/aAges 6 Years - 70 YearsAllHospices Civils de Lyon
NCT06430359 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 elimina

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📋 Eligibility rules (as published)
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
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What it tests

  • urine and blood test
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Where

1 site
Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant
Bron, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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