Examining copper levels in breast milk of pregnant women with Wilson's disease
Description of the Copper Concentration in Breast Milk in Women Treated for Wilson's Disease
This study tests how treatment for Wilson's disease affects copper levels in the breast milk of pregnant women to ensure the health of both mom and baby during breastfeeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Trial ID | NCT05183165 on ClinicalTrials.gov |
What this trial studies
This study investigates the concentration of copper in breast milk from women diagnosed with Wilson's disease who are currently pregnant. Wilson's disease is a genetic disorder that leads to copper accumulation in the body, and this research aims to understand how treatment during pregnancy affects copper levels in breast milk. Participants will include women over 18 years old who meet specific criteria related to Wilson's disease and pregnancy. The study will monitor copper levels to ensure the health of both mother and child during breastfeeding.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older who have been diagnosed with Wilson's disease.
Not a fit: Patients who have undergone a liver transplant or cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of breastfeeding for mothers with Wilson's disease and their infants.
How similar studies have performed: While studies on copper metabolism in Wilson's disease exist, this specific focus on breast milk during pregnancy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Criteria for inclusion : * Patient aged 18 years or over. * Wilson's disease fulfilling the criteria for the Leipzig score * Pregnancy in progress whatever the term. * Express consent to participate in the study. * Affiliate or beneficiary of a social security system. Criteria for non-inclusion : * Liver transplant patient * No affiliation to Social Security system * VuInability to give free and informed consent * Patient benefiting from a legal protection measure
Where this trial is running
Paris
- Fondation Adolphe de Rothschild — Paris, France (Recruiting)
Study contacts
- Study coordinator: Amélie YAVCHITZ
- Email: ayavhitz@for.paris
- Phone: 01 48 03 64 54
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.