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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT01457690

First received: October 18, 2011

Last updated: June 5, 2013

Last verified: June 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2011

Last Updated Date

June 5, 2013

Start Date ^ICMJE

June 2011

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01457690 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measurement of serum (membranes erythrocytic) of vitamin E at the beginning and after each treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Hypobetalipoproteinemias

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Drug: Tocofersolan
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

Intervention: Drug: tocopherol alpha

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

6 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01457690

Other Study ID Numbers ^ICMJE

2010.634

Has Data Monitoring Committee

Responsible Party

Hospices Civils de Lyon

Study Sponsor ^ICMJE

Hospices Civils de Lyon

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Noel PERETTI, MD, PhD

Hopital Femme Mere Enfant, Hospices Civils de Lyon

Information Provided By

Hospices Civils de Lyon

Verification Date

June 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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