Status:
COMPLETED
Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Hypobetalipoproteinemias
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
To evaluate the kinetics of intestinal absorption of vitamin E water-soluble form from the classical lipid-soluble form in a population of patients with intestinal malabsorption (hypocholesterolemias ...
Eligibility Criteria
Inclusion
- Patient suffering from familial hypocholesterolemia by retention of chylomicrons
- Systematically followed in the department of Gastroenterology and Paediatric Nutrition in Women Mother Child's Hospital or in the endocrinology department of GHE (Louis Pradel Hospital);
- During treatment with oral vitamin E;
- over the age of 3 years and weighing over 16 kg at the time of inclusion
- For which there is a signed informed consent from the patient or parents / guardians in the case of a minor patient, and benefit from social security coverage.
Exclusion
- Patient with encephalopathy
- Hypersensitivity to the active substance or the excipients of Vedrop
- A suspected allergy to local anaesthetics (including xylocaine)
- Patients who may not be compliant to treatment (psychiatric);
- In case of refusal to participate in the study from the patient and / or parents or legal guardian;
- Patients unable to consent (if patients with encephalopathy)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01457690
Start Date
October 1 2011
End Date
August 1 2015
Last Update
August 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Femme Mere Enfant-Hospices Civils de Lyon
Bron, France, 69677