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Completed

NCT Number: NCT01457690

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

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).

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Key information

Conditions

Hypobetalipoproteinemias Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hypolipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopital Femme Mere Enfant-Hospices Civils de Lyon

Bron, 69677, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tocofersolan

Drug

Administration of a daily dose of vitamin E for 4 months:50 IU/kg

tocopherol alpha

Drug

Administration of a daily dose of vitamin E for 4 months:50 IU/kg

Tocofersolan and tocopherol alpha

Drug

Administration of a single dose of vitamin E (Vitamin E water-soluble then Vitamin E conventional fat-soluble form)

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: VEDROP

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 24, 2011
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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