Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients

Not yet recruiting

• Conditions: Wilson Disease
• Interventions: Diagnostic Test: urine and blood test

• Registration Number: NCT06430359
• Lead Sponsor: Hospices Civils de Lyon

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Study Start: 2024-07-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 - DP	urine and blood test	Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with D-Pencillamine
Group 3 - ZINC	urine and blood test	Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Zinc.
Group 2 - Trientine	urine and blood test	Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ˃4 ). Aged between 6 years and 70 years. Treated with Trientine

Primary Outcome Measures

Name	Time	Method
Correlation factor	Two 24-hour urine recollection	Correlation between 24-hour urinary copper excretion and 8-hour urinary copper excretion collected between midnight and 8 am).

Trial Locations

Locations (1)

Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant; 🇫🇷 Bron, Rhone, France