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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Hypobetalipoproteinemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tocofersolan: Vitamin E water-soluble

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

Group Type EXPERIMENTAL

Tocofersolan

Intervention Type DRUG

Administration of a daily dose of vitamin E for 4 months:50 IU/kg

Tocopherol alpha: Vitamin E conventional fat-soluble form

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

Group Type ACTIVE_COMPARATOR

tocopherol alpha

Intervention Type DRUG

Administration of a daily dose of vitamin E for 4 months:50 IU/kg

volunteers

Group Type ACTIVE_COMPARATOR

Tocofersolan and tocopherol alpha

Intervention Type DRUG

Administration of a single dose of vitamin E (Vitamin E water-soluble then Vitamin E conventional fat-soluble form)

Interventions

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Tocofersolan

Administration of a daily dose of vitamin E for 4 months:50 IU/kg

Intervention Type DRUG

tocopherol alpha

Administration of a daily dose of vitamin E for 4 months:50 IU/kg

Intervention Type DRUG

Tocofersolan and tocopherol alpha

Administration of a single dose of vitamin E (Vitamin E water-soluble then Vitamin E conventional fat-soluble form)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes