Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C

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.

Study Overview

• Status: Completed
• Conditions: Bioavailability of Vitamin C
• Intervention / Treatment: Dietary supplement: Traditional Vitamin C; Dietary supplement: Liposomal Vitamin C

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • Medical University of Warsaw

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Experimental: Liposomal Vitamin C; Single oral dose of liposomal vitamin C formulation	Dietary supplement: Liposomal Vitamin C; 1000 mg of ascorbic acid in liposomal 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	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: AronPharma Sp. z o. o.
• Collaborators: Medical University of Warsaw; Medical University of Gdansk

Study record dates

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 (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Ascorbic Acid; Liposomal Vitamin C
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamins; Ascorbic Acid
• 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