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

Hypobetalipoproteinemias Clinical Trial

— VEDROP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457690
• Other study ID #: 2010.634
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2011
• Last updated: November 12, 2015
• Start date: October 2011
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypobetalipoproteinemias

Intervention

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

Locations

Country	Name	City	State
France	Hopital Femme Mere Enfant-Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Measurement of serum (membranes erythrocytic) of vitamin E at the beginning and after each treatment.	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.	12 months	No
Secondary	Measurement of tissue (subcutaneous adipose tissue) of vitamin E at the beginning and after each treatment.	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.	12 months	No