Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C

Not Applicable

Completed

• Conditions: Bioavailability of Vitamin C
• Interventions: Dietary Supplement: Liposomal Vitamin C; Dietary Supplement: Traditional Vitamin C

• Registration Number: NCT05843617
• Lead Sponsor: AronPharma Sp. z o. o.

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 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 Timeline

• Study Start: 2022-02-28
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-09
• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-05-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Liposomal Vitamin C	Liposomal Vitamin C	Single oral dose of liposomal vitamin C formulation
Traditional Vitamin C	Traditional Vitamin C	Single oral dose of traditional vitamin C formulation

Primary Outcome Measures

Name	Time	Method
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
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)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Warsaw; 🇵🇱 Warsaw, Poland