Hypobetalipoproteinemias
Conditions
Keywords
Vitamin E pegylated, chylomicron retention, Familial Hypocholesterolemia, Hypobetalipoproteinemias
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 family by retention of chylomicrons).
Interventions
DRUGTocofersolan
Administration of a daily dose of vitamin E for 4 months:50 IU/kg
DRUGtocopherol alpha
Administration of a daily dose of vitamin E for 4 months:50 IU/kg
DRUGTocofersolan and tocopherol alpha
Administration of a single dose of vitamin E (Vitamin E water-soluble then Vitamin E conventional fat-soluble form)
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement the area under the curve of absorption of vitamin E according to its dosage form (fat-soluble versus water-soluble) in the beginning of each treatment period. versus water-soluble) in the beginning of each treatment period. | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of serum (membranes erythrocytic) of vitamin E at the beginning and after each treatment. | 12 months | Measurement of serum (membranes erythrocytic) of vitamin E at the beginning and after each treatment. Search for a correlation between the rates in adipose tissue and those in the membrane of erythrocytes. |
| Measurement of tissue (subcutaneous adipose tissue) of vitamin E at the beginning and after each treatment. | 12 months | Measurement of tissue (subcutaneous adipose tissue) of vitamin E at the beginning and after each treatment. Search for a correlation between the rates in adipose tissue and those in the membrane of erythrocytes. |
Countries
France
Outcome results
None listed