Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention (VEDROP)

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Hypobetalipoproteinemias

Treatments: Drug: Tocofersolan and tocopherol alpha; Drug: Tocofersolan; Drug: tocopherol alpha

Study type: Interventional

Funder types: Other

Identifiers

NCT01457690

2010.634

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 3 patient groups

Tocofersolan: Vitamin E water-soluble

Experimental group

Description:

2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months

Treatment:

Drug: Tocofersolan

Tocopherol alpha: Vitamin E conventional fat-soluble form

Active Comparator group

Description:

2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months

Treatment:

Drug: tocopherol alpha

volunteers

Active Comparator group

Treatment:

Drug: Tocofersolan and tocopherol alpha