Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06430359

Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

6 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant

Bron, Rhone, 69500, France

Location status: Recruiting

Location contact

Abdelouahed BELMALIH, PhD

CONTACT

[email protected]

04 27 85 62 67 ext. +33

Eduardo Couchonnal, Dr

CONTACT

[email protected]

04 27 35 70 50 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urine and blood test

Diagnostic Test

3 urine collections of an 8h period. One blood sample for liver function test and copper assessment

Primary outcomes

  1. Correlation factor

    Time frame: Two 24-hour urine recollection

    Correlation between 24-hour urinary copper excretion and 8-hour urinary copper excretion collected between midnight and 8 am).

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelouahed BELMALIH, PhD

CONTACT

[email protected]

04 27 85 62 67 ext. +33

Eduardo COUCHONNAL, Dr

CONTACT

[email protected]

04 27 35 70 50 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts

Acronym: VARCUWIC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 28, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.