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| Name | Class |
|---|---|
| Medical University of Warsaw | OTHER |
| Medical University of Gdansk | OTHER |
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The aim of the study was to compare the profiles of vitamin C serum concentration in healthy volunteers after the single oral administration either in a liposomal or traditional formulation.
The randomized, double-blind, cross-over study was conducted under the supervision of physician on a group of 10 healthy subjects. The volunteers received 1g of vitamin C in a traditional formulation (powder in capsules), and after 14 days of a washout period 1 gram of liposomal formulation (powder in capsules). Venous blood was collected from each participant of the study immediately before the administration of a studied substance and 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 24 hours post the administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Vitamin C | Experimental | Single oral dose of liposomal vitamin C formulation |
|
| Traditional Vitamin C | Active Comparator | Single oral dose of traditional vitamin C formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Vitamin C | Dietary Supplement | 1000 mg of ascorbic acid in liposomal formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of ascorbic acid that has been absorbed, defined as AUC | Comparison of the bioavailability of formulations based on the total amount of ascorbic acid that has been absorbed, defined as AUC (area under the curve) | baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration |
| Maximum concentration of ascorbic acid (Cmax) | Maximum concentration of ascorbic acid achieved in the blood after administration of both formulations | baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of ascorbic acid after 24 hours (C24h) | Comparison of the concentration achieved in the blood after 24 hours (C24h) from the administration of both formulations | 24 hours post the administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw | Warsaw | Poland |
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| Traditional Vitamin C | Dietary Supplement | 1000 mg of ascorbic acid in traditional formulation |
|