Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
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
- The protocol lists: urine and blood test.
- Who it may be relevant to
- Registry conditions: Wilson Disease. Basic parameters: 6 years — 70 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
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts
Overview
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
Interventions
- Diagnostic test urine and blood test
3 urine collections of an 8h period. One blood sample for liver function test and copper assessment
Primary outcome measures
- Correlation factor [Time frame: Two 24-hour urine recollection]
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
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
France · 1 center
- Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère E — Bron
Identifiers
NCT: NCT06430359 · 69HCL23_1227