- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05843617
Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C
April 25, 2023 updated by: AronPharma Sp. z o. o.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Warsaw, Poland
- Medical University of Warsaw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Women and men, 18-65 years old.
- Signed informed consent.
- No injuries or hospitalizations within the last 3 months.
- 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.
- Participants should fast for at least 8-12 hours prior to the administration of the preparations.
Exclusion Criteria:
- Unwilling to give consent.
- Injuries within the last 3 months.
- Cancer (current or past).
- Renal dysfunction (eGFR < 60 ml/min).
- Gastrointestinal disorders (including use of antacids).
- Tobacco use in any form.
- Pregnancy/breastfeeding.
- Patient after organ transplantation, after a stroke, use of anticoagulants, use of immunosuppressants.
- Female patient receiving hormonal therapy (contraception).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liposomal Vitamin C (Liposovit-C)
Single oral dose of liposomal vitamin C formulation
|
1000 mg of ascorbic acid in liposomal formulation
|
Active Comparator: Traditional Vitamin C
Single oral dose of traditional vitamin C formulation
|
1000 mg of ascorbic acid in traditional formulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total amount of ascorbic acid that has been absorbed, defined as AUC
Time Frame: 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)
|
baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration
|
Maximum concentration of ascorbic acid (Cmax)
Time Frame: 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
|
baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of ascorbic acid after 24 hours (C24h)
Time Frame: 24 hours post the administration
|
Comparison of the concentration achieved in the blood after 24 hours (C24h) from the administration of both formulations
|
24 hours post the administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2022
Primary Completion (Actual)
June 9, 2022
Study Completion (Actual)
June 9, 2022
Study Registration Dates
First Submitted
April 25, 2023
First Submitted That Met QC Criteria
April 25, 2023
First Posted (Estimate)
May 4, 2023
Study Record Updates
Last Update Posted (Estimate)
May 4, 2023
Last Update Submitted That Met QC Criteria
April 25, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-AP-VC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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