Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C
Study Details
Study Description
Brief Summary
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 (Liposovit-C pure) or traditional formulation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Liposovit-C pure (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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Liposomal Vitamin C (Liposovit-C) Single oral dose of liposomal vitamin C formulation |
Dietary Supplement: Liposomal Vitamin C (Liposovit-C)
1000 mg of ascorbic acid in liposomal formulation
|
| Active Comparator: Traditional Vitamin C Single oral dose of traditional vitamin C formulation |
Dietary Supplement: Traditional Vitamin C
1000 mg of ascorbic acid in traditional formulation
|
Outcome Measures
Primary Outcome Measures
- Total amount of ascorbic acid that has been absorbed, defined as AUC [baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration]
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)
- Maximum concentration of ascorbic acid (Cmax) [baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration]
Maximum concentration of ascorbic acid achieved in the blood after administration of both formulations
Secondary Outcome Measures
- Concentration of ascorbic acid after 24 hours (C24h) [24 hours post the administration]
Comparison of the concentration achieved in the blood after 24 hours (C24h) from the administration of both formulations
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women and men, 18-65 years old.
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Signed informed consent.
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No injuries or hospitalizations within the last 3 months.
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Refraining from consuming any vitamin C supplements or foods enriched with vitamin C for a period of 72 hours. Limiting excessive consumption of red peppers, parsley (stalks), Brussels sprouts, broccoli, turnip, tomatoes, cabbage, spinach, watercress, citrus fruits, and citrus juices. Not taking acetylsalicylic acid (aspirin, polopiryna, etopiryna) during the study.
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Participants should fast for at least 8-12 hours prior to the administration of the preparations.
Exclusion Criteria:
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Unwilling to give consent.
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Injuries within the last 3 months.
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Cancer (current or past).
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Renal dysfunction (eGFR < 60 ml/min).
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Gastrointestinal disorders (including use of antacids).
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Tobacco use in any form.
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Pregnancy/breastfeeding.
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Patient after organ transplantation, after a stroke, use of anticoagulants, use of immunosuppressants.
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Female patient receiving hormonal therapy (contraception).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Warsaw | Warsaw | Poland |
Sponsors and Collaborators
- AronPharma Sp. z o. o.
- Medical University of Warsaw
- Medical University of Gdańsk
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 01-AP-VC