Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C

NCT ID: NCT05843617

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-06-09

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.

Conditions

Bioavailability of Vitamin C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Liposomal Vitamin C

Single oral dose of liposomal vitamin C formulation

Group Type: EXPERIMENTAL

Liposomal Vitamin C

Intervention Type: DIETARY_SUPPLEMENT

1000 mg of ascorbic acid in liposomal formulation

Traditional Vitamin C

Single oral dose of traditional vitamin C formulation

Group Type: ACTIVE_COMPARATOR

Traditional Vitamin C

Intervention Type: DIETARY_SUPPLEMENT

1000 mg of ascorbic acid in traditional formulation

Interventions

Liposomal Vitamin C

1000 mg of ascorbic acid in liposomal formulation

Intervention Type: DIETARY_SUPPLEMENT

Traditional Vitamin C

1000 mg of ascorbic acid in traditional formulation

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: collaborator

Medical University of Gdansk

OTHER

Sponsor Role: collaborator

AronPharma Sp. z o. o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Warsaw

Warsaw, , Poland

Countries

Poland

Other Identifiers

01-AP-VC

Identifier Type: -

Identifier Source: org_study_id