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

Phase 3

Completed

• Conditions: Hypobetalipoproteinemias
• Interventions: Drug: Tocofersolan; Drug: tocopherol alpha; Drug: Tocofersolan and tocopherol alpha

• Registration Number: NCT01457690
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-24
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-12
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tocofersolan: Vitamin E water-soluble	Tocofersolan	2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months
Tocopherol alpha: Vitamin E conventional fat-soluble form	tocopherol alpha	2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months
volunteers	Tocofersolan and tocopherol alpha	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hopital Femme Mere Enfant-Hospices Civils de Lyon; 🇫🇷 Bron, France