HypobetalipoproteinemiasPhase 3VEDROPNCT01457690
Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention
A Phase 3 study testing Tocofersolan, tocopherol alpha and Tocofersolan and tocopherol alpha in people with Hypobetalipoproteinemias, run by Hospices Civils de Lyon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypobetalipoproteinemias
- What is being tested?
- Tocofersolan, tocopherol alpha and Tocofersolan and tocopherol alpha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Hypobetalipoproteinemias
- Being tested
- Tocofersolan, tocopherol alpha, Tocofersolan and tocopherol alpha
- Keywords
- Vitamin E pegylated, chylomicron retention, Familial Hypocholesterolemia, Hypobetalipoproteinemias
- Medical subject headings
- Hypobetalipoproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocofersolanDrug
Administration of a daily dose of vitamin E for 4 months:50 IU/kg
tocopherol alphaDrug
Administration of a daily dose of vitamin E for 4 months:50 IU/kg
Tocofersolan and tocopherol alphaDrug
Administration of a single dose of vitamin E (Vitamin E water-soluble then Vitamin E conventional fat-soluble form)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: tocopherol alpha |
| volunteers | Active comparator | Not described Receives: Drug: Tocofersolan and tocopherol alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Measurement of serum (membranes erythrocytic) of vitamin E at the beginning and after each treatment.
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.
Measured: 12 months
Measurement of tissue (subcutaneous adipose tissue) of vitamin E at the beginning and after each treatment.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypobetalipoproteinemiasStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noel PERETTI, MD, PhD, Principal investigator, Hopital Femme Mere Enfant, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457690
- Sponsor's protocol ID
- 2010.634
- Acronym
- VEDROP
- Status last verified
- Nov 2015
- First submitted
- 18 Oct 2011
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30021760
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention
- ClinicalTrials.gov ID
- NCT01457690
- Acronym / sponsor ID
- VEDROP / 2010.634
- Conditions
- Hypobetalipoproteinemias
- Keywords
- Vitamin E pegylated, chylomicron retention, Familial Hypocholesterolemia, Hypobetalipoproteinemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tocofersolan: Vitamin E water-soluble | Experimental | Drug: Tocofersolan2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months |
| Tocopherol alpha: Vitamin E conventional fat-soluble form | Active comparator | Drug: tocopherol alpha2 months off the conventional treatment before the study. Administration of a daily dose of vitamin E for 4 months |
| volunteers | Active comparator | Drug: Tocofersolan and tocopherol alpha |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocofersolanAdministration of a daily dose of vitamin E for 4 months:50 IU/kg | Drug | Tocofersolan: Vitamin E water-soluble |
| tocopherol alphaAdministration of a daily dose of vitamin E for 4 months:50 IU/kg | Drug | Tocopherol alpha: Vitamin E conventional fat-soluble form |
| Tocofersolan and tocopherol alphaAdministration of a single dose of vitamin E (Vitamin E water-soluble then Vitamin E conventional fat-soluble form) | Drug | volunteers |
Primary outcome
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
2 secondary outcomes
Measurement of serum (membranes erythrocytic) 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.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Results publication: PubMed 30021760Cuerq 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel PERETTI, MD, PhD principal investigator
Hopital Femme Mere Enfant, Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocofersolan, tocopherol alpha and Tocofersolan and tocopherol alpha in people with Hypobetalipoproteinemias, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01457690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.