NCT01457690

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 22, 2025

Status Verified

November 1, 2015

Enrollment Period

3.8 years

First QC Date

October 18, 2011

Last Update Submit

August 20, 2025

Conditions

Hypobetalipoproteinemias

Keywords

Vitamin E pegylatedchylomicron retentionFamilial HypocholesterolemiaHypobetalipoproteinemias

Outcome Measures

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.

    12 months

Secondary Outcomes (2)

  • Measurement of serum (membranes erythrocytic) of vitamin E at the beginning and after each treatment.

    12 months

  • Measurement of tissue (subcutaneous adipose tissue) of vitamin E at the beginning and after each treatment.

    12 months

Study Arms (3)

Tocofersolan: Vitamin E water-soluble

EXPERIMENTAL

2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months

Drug: Tocofersolan

Tocopherol alpha: Vitamin E conventional fat-soluble form

ACTIVE COMPARATOR

2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months

Drug: tocopherol alpha

volunteers

ACTIVE COMPARATOR
Drug: Tocofersolan and tocopherol alpha

Interventions

TocofersolanDRUG

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

Tocofersolan: Vitamin E water-soluble
tocopherol alphaDRUG

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

Tocopherol alpha: Vitamin E conventional fat-soluble form
Tocofersolan and tocopherol alphaDRUG

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

volunteers

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Femme Mere Enfant-Hospices Civils de Lyon

Bron, 69677, France

Location

Related Publications (1)

  • Cuerq C, Henin E, Restier L, Blond E, Drai J, Marcais C, Di Filippo M, Laveille C, Michalski MC, Poinsot P, Caussy C, Sassolas A, Moulin P, Reboul E, Charriere S, Levy E, Lachaux A, Peretti N. Efficacy of two vitamin E formulations in patients with abetalipoproteinemia and chylomicron retention disease. J Lipid Res. 2018 Sep;59(9):1640-1648. doi: 10.1194/jlr.M085043. Epub 2018 Jul 18.

    PMID: 30021760RESULT

MeSH Terms

Conditions

Hypobetalipoproteinemias

Interventions

tocophersolanalpha-Tocopherol

Condition Hierarchy (Ancestors)

HypolipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TocopherolsVitamin EBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Noel PERETTI, MD, PhD

    Hopital Femme Mere Enfant, Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 24, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 22, 2025

Record last verified: 2015-11

Locations

FR(1)