Trial record 13 of 15 for:    "Hypolipoproteinemia"

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. (see Contacts and Locations)
Verified May 2014 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: May 21, 2014
Last verified: May 2014
  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
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:


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: 14
Study Start Date: October 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 21, 2014
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:
Hypolipoproteinemias
Hypobetalipoproteinemias
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014