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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 is currently recruiting participants.
Verified October 2011 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01457690
First received: October 18, 2011
Last updated: October 20, 2011
Last verified: October 2011
History of Changes
  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
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 7
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (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

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457690

Contacts
Contact: Noel PERETTI, MD,PhD +33 4.27.85.77.02 noel.peretti@chu-lyon.fr

Locations
France
Hopital Femme Mere Enfant-Hospices Civils de Lyon Recruiting
Bron, France, 69677
Contact: Lioara RESTIER, MSc, PhD     + 33 (0) 427 856 020     lioara.restier@chu-lyon.fr    
Principal Investigator: Noel PERETTI, MD,PhD            
Sub-Investigator: Irene LORAS- DUCLAUX, MD            
Sub-Investigator: Alain LACHAUX, MD,PhD            
Sub-Investigator: Philippe MOULIN, MD,PhD            
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Noel PERETTI, MD, PhD Hopital Femme Mere Enfant, Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01457690     History of Changes
Other Study ID Numbers: 2010.634
Study First Received: October 18, 2011
Last Updated: October 20, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 16, 2013