Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
ConditionWilson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-70
SponsorHospices Civils de Lyon
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
\- Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
urine and blood test
Diagnostic test3 urine collections of an 8h period. One blood sample for liver function test and copper assessment
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Group 1 - DP1 intervention
Group B: Group 2 - Trientine1 intervention
Group C: Group 3 - ZINC1 intervention
Trial outcomes
Primary outcomes
1
Correlation factor
Correlation between 24-hour urinary copper excretion and 8-hour urinary copper excretion collected between midnight and 8 am).
Time frame
Two 24-hour urine recollectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov