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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| volunteers | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocofersolan | Drug | Administration of a daily dose of vitamin E for 4 months:50 IU/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noel PERETTI, MD, PhD | Hopital Femme Mere Enfant, Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Femme Mere Enfant-Hospices Civils de Lyon | Bron | 69677 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30021760 | Result | 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. |
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| 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) |
|
| 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. |
| 12 months |
| ID | Term |
|---|---|
| D006995 | Hypobetalipoproteinemias |
| ID | Term |
|---|---|
| D007009 | Hypolipoproteinemias |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C014225 | tocophersolan |
| D024502 | alpha-Tocopherol |
| ID | Term |
|---|---|
| D024505 | Tocopherols |
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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