Back to resultsStudy of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention (VEDROP)
Primary Purpose
Hypobetalipoproteinemias
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Tocofersolan
tocopherol alpha
Tocofersolan and tocopherol alpha
Sponsored by
About this trial
This is an interventional treatment trial for Hypobetalipoproteinemias focused on measuring Vitamin E pegylated, chylomicron retention, Familial Hypocholesterolemia, Hypobetalipoproteinemias
Eligibility Criteria
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)
Sites / Locations
- Hopital Femme Mere Enfant-Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Tocofersolan: Vitamin E water-soluble
Tocopherol alpha: Vitamin E conventional fat-soluble form
volunteers
Arm Description
2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months
2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months
Outcomes
Primary Outcome 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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01457690
First Posted
October 18, 2011
Last Updated
November 12, 2015
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT01457690
Brief Title
Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention
Acronym
VEDROP
Official Title
Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypobetalipoproteinemias
Keywords
Vitamin E pegylated, chylomicron retention, Familial Hypocholesterolemia, Hypobetalipoproteinemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tocofersolan: Vitamin E water-soluble
Arm Type
Experimental
Arm Description
2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months
Arm Title
Tocopherol alpha: Vitamin E conventional fat-soluble form
Arm Type
Active Comparator
Arm Description
2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months
Arm Title
volunteers
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tocofersolan
Intervention Description
Administration of a daily dose of vitamin E for 4 months:50 IU/kg
Intervention Type
Drug
Intervention Name(s)
tocopherol alpha
Intervention Description
Administration of a daily dose of vitamin E for 4 months:50 IU/kg
Intervention Type
Drug
Intervention Name(s)
Tocofersolan and tocopherol alpha
Intervention Description
Administration of a single dose of vitamin E (Vitamin E water-soluble then Vitamin E conventional fat-soluble form)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Measurement of serum (membranes erythrocytic) of vitamin E at the beginning and after each treatment.
Description
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.
Time Frame
12 months
Title
Measurement of tissue (subcutaneous adipose tissue) of vitamin E at the beginning and after each treatment.
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel PERETTI, MD, PhD
Organizational Affiliation
Hopital Femme Mere Enfant, Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Femme Mere Enfant-Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention
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