Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-21
Brief Title:
Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VARCUWIC
Brief Summary:
Wilsons 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 patients 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
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 patients 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None