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 family by retention of chylomicrons).
Drug: tocopherol alpha
Drug: Tocofersolan and tocopherol alpha
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Full eligibility criteria for NCT01457690
Ages eligible for Study
6 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.
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)
All locations for NCT01457690
Hopital Femme Mere Enfant-Hospices Civils de Lyon
Bron, France, 69677
View full eligibility
Tris trial is registered with FDA with number: NCT01457690. The sponsor of the trial is Hospices Civils de Lyon and it is looking for 14 volunteers for the current phase.
Official trial title: Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention
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