Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C

NCT05843617 | Completed

• 1 other identifier: 01-AP-VC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability of Vitamin C

Keywords

Ascorbic Acid; Liposomal Vitamin C

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Concentration of ascorbic acid after 24 hours (C24h)

  24 hours post the administration

Study Arms (2)

Liposomal Vitamin C

EXPERIMENTAL

Single oral dose of liposomal vitamin C formulation

Dietary Supplement: Liposomal Vitamin C

Traditional Vitamin C

ACTIVE COMPARATOR

Single oral dose of traditional vitamin C formulation

Dietary Supplement: Traditional Vitamin C

Interventions

Liposomal Vitamin C DIETARY_SUPPLEMENT

1000 mg of ascorbic acid in liposomal formulation

Liposomal Vitamin C

Traditional Vitamin C DIETARY_SUPPLEMENT

1000 mg of ascorbic acid in traditional formulation

Traditional Vitamin C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AronPharma Sp. z o. o.: lead
• Medical University of Warsaw: collaborator
• Medical University of Gdansk: collaborator

Study Sites (1)

Medical University of Warsaw

Warsaw, Poland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: February 28, 2022
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)