Bioavailability of Vitamin CNCT05843617
Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C
A study testing Liposomal Vitamin C and Traditional Vitamin C in people with Bioavailability of Vitamin C, run by AronPharma Sp. z o. o. at 1 site in Poland.
Trial 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 or traditional formulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability of Vitamin C
- What is being tested?
- Liposomal Vitamin C and Traditional Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePoland
- Study dates
- 28 Feb 2022to 9 Jun 2022
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnancy/breastfeeding.
- Patient after organ transplantation, after a stroke, use of anticoagulants, use of immunosuppressants.
- Female patient receiving hormonal therapy (contraception).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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.
- Conditions
- Bioavailability of Vitamin C
- Being tested
- Liposomal Vitamin C, Traditional Vitamin C
- Keywords
- Ascorbic Acid, Liposomal Vitamin C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Vitamin CDietary supplement
1000 mg of ascorbic acid in liposomal formulation
Traditional Vitamin CDietary supplement
1000 mg of ascorbic acid in traditional formulation
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Vitamin C | Experimental | Single oral dose of liposomal vitamin C formulation Receives: Dietary Supplement: Liposomal Vitamin C |
| Traditional Vitamin C | Active comparator | Single oral dose of traditional vitamin C formulation Receives: Dietary Supplement: Traditional Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration
Secondary outcomes (1)
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
Measured: 24 hours post the administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start28 Feb 2022
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability of Vitamin CStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AronPharma Sp. z o. o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Warsaw, Medical University of Gdansk
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843617
- Sponsor's protocol ID
- 01-AP-VC
- Status last verified
- Jul 2024
- First submitted
- 25 Apr 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C
- ClinicalTrials.gov ID
- NCT05843617
- Acronym / sponsor ID
- 01-AP-VC
- Conditions
- Bioavailability of Vitamin C
- Keywords
- Ascorbic Acid, Liposomal Vitamin C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AronPharma Sp. z o. o.Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Warsaw, Medical University of Gdansk
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 6 May 2023 (actual)
- 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.
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.
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 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Vitamin C | Experimental | Dietary Supplement: Liposomal Vitamin CSingle oral dose of liposomal vitamin C formulation |
| Traditional Vitamin C | Active comparator | Dietary Supplement: Traditional Vitamin CSingle oral dose of traditional vitamin C formulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
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 |
|---|---|---|
| Liposomal Vitamin C1000 mg of ascorbic acid in liposomal formulation | Dietary supplement | Liposomal Vitamin C |
| Traditional Vitamin C1000 mg of ascorbic acid in traditional formulation | Dietary supplement | Traditional Vitamin C |
Primary outcome
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)
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
1 secondary outcome
Concentration of ascorbic acid after 24 hours (C24h)
Time frame: 24 hours post the administration
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 1 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Bioavailability of Vitamin C
Recruiting
Effect of Chitin and Ascorbic Acid on Dietary Insect Iron Absorption
Iron Deficiency (Without Anemia)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal Vitamin C and Traditional Vitamin C in people with Bioavailability of Vitamin C, run by AronPharma Sp. z o. o. at 1 site in Poland.
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 9 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 1 Aug 2024. 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 Poland. 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.
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?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024.