Actively Recruiting
Description of the Copper Concentration in Breast Milk in Women Treated for Wilson's Disease
Led by Fondation Ophtalmologique Adolphe de Rothschild · Updated on 2025-12-17
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Wilson's disease is a rare genetic disorder caused by mutations in the ATP7B gene, affecting copper transport in the body. This leads to copper buildup mainly in the liver, eyes, and brain. Advances in treatment have improved outlooks, allowing women with Wilson's disease to consider pregnancy more confidently. The study aims to understand copper levels in breast milk among women treated for this condition during pregnancy. The study will involve pregnant women with Wilson's disease who are receiving treatment. These patients will be followed in specialized centers across France. Researchers will assess copper concentration in breast milk collected one day after childbirth. Biological assessments of blood and urine, along with dietary evaluations, will also be conducted to monitor health and treatment impact. Participants will provide breast milk samples shortly after delivery for copper level analysis. The primary outcome is measuring total copper concentration in the milk. The study will track participants during pregnancy and postpartum, ensuring treatment and health status are monitored. The goal is to evaluate breastfeeding safety and inform recommendations for mothers with Wilson's disease, with participation lasting throughout pregnancy and shortly after birth.
CONDITIONS
Brief Title
Description of the Copper Concentration in Breast Milk in Women Treated for Wilson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years or over
- Diagnosed with Wilson's disease according to Leipzig score criteria
- Currently pregnant, regardless of pregnancy term
- Able and willing to give informed consent
- Affiliated or beneficiary of a social security system
You will not qualify if you...
- History of liver transplant
- Not affiliated with a social security system
- Unable to give free and informed consent
- Under legal protection measures that prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day ± 24 hours after childbirth
Participants provide a breast milk sample approximately 1 day after childbirth for copper concentration measurement. Additional blood and urine assessments and dietary evaluations may be performed.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Fondation Adolphe de Rothschild
Paris, France, 75019
Actively Recruiting
Research Team
A
Amélie YAVCHITZ
M
Mickael Alexandre OBADIA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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