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

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2015

Interventions

  • Drug: Tocofersolan
    • Administration of a daily dose of vitamin E for 4 months:50 IU/kg
  • Drug: tocopherol alpha
    • Administration of a daily dose of vitamin E for 4 months:50 IU/kg
  • Drug: Tocofersolan and tocopherol alpha
    • Administration of a single dose of vitamin E (Vitamin E water-soluble then Vitamin E conventional fat-soluble form)

Arms, Groups and Cohorts

  • Experimental: 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
  • Active Comparator: 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
  • Active Comparator: volunteers

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 12 months

Secondary Measures

  • Measurement of serum (membranes erythrocytic) of vitamin E at the beginning and after each treatment.
    • Time Frame: 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.
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Noel PERETTI, MD, PhD, Principal Investigator, Hopital Femme Mere Enfant, Hospices Civils de Lyon

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