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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01457690
First Posted: October 24, 2011
Last Update Posted: November 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
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).

Condition Intervention Phase
Hypobetalipoproteinemias Drug: Tocofersolan Drug: tocopherol alpha Drug: Tocofersolan and tocopherol alpha Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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. [ Time Frame: 12 months ]

Secondary Outcome 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.


Enrollment: 14
Study Start Date: October 2011
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Tocofersolan
Administration of a daily dose of vitamin E for 4 months:50 IU/kg
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
Drug: tocopherol alpha
Administration of a daily dose of vitamin E for 4 months:50 IU/kg
Active Comparator: volunteers Drug: Tocofersolan and tocopherol alpha
Administration of a single dose of vitamin E (Vitamin E water-soluble then Vitamin E conventional fat-soluble form)

  Eligibility

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457690


Locations
France
Hopital Femme Mere Enfant-Hospices Civils de Lyon
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Noel PERETTI, MD, PhD Hopital Femme Mere Enfant, Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01457690     History of Changes
Other Study ID Numbers: 2010.634
First Submitted: October 18, 2011
First Posted: October 24, 2011
Last Update Posted: November 13, 2015
Last Verified: November 2015

Keywords provided by Hospices Civils de Lyon:
Vitamin E pegylated
chylomicron retention
Familial Hypocholesterolemia
Hypobetalipoproteinemias

Additional relevant MeSH terms:
Hypolipoproteinemias
Hypobetalipoproteinemias
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents