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Completed

NCT Number: NCT05843617

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Warsaw

Warsaw, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

liposomal vitamin C

Dietary Supplement

1000 mg of ascorbic acid in liposomal formulation

Traditional Vitamin C

Dietary Supplement

1000 mg of ascorbic acid in traditional formulation

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AronPharma Sp. z o. o.

Industry

Collaborators

  • Medical University of Gdansk
  • Medical University of Warsaw

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 6, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.