Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3

Not Applicable

Completed

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

• Registration Number: NCT06010121
• Lead Sponsor: AronPharma Sp. z o. o.

Brief Summary

The aim of the study was to compare the profiles of 25-hydroxyvitamin D serum concentration in healthy adults after 4 weeks of using vitamin D supplementation either in a liposomal or a traditional formulation.

Detailed Description

The study will be randomized, cross-over, participants will be randomly assigned to one of the study groups: A) the group receiving vitamin D3 in traditional formulation B) the group receiving vitamin D3 in liposomal formulation. The day before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation, participants will have their blood drawn. Then, after a wash-out period of 2 months, the groups will be switched. Participants will again receive daily supplementation with vitamin D3 for 4 weeks. Blood will be drawn before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation.

Study Timeline

• Study Start: 2023-02-17
• Primary Completion: 2023-06-06
• Study Completion: 2023-06-06
• Status Verified: 2023-08
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-24
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Women and men, 18-60 years old.
• Signed informed consent.
• No injuries or hospitalizations within the last 3 months.
• No vitamin D supplementation for the 2 months prior to the study initiation.
• Refraining for the period of the clinical trial from consuming foods additionally fortified with vitamin D and dietary supplements containing vitamin D
• Refraining for the period of the clinical trial from the use of cosmetic therapies that use prolonged body illumination

Exclusion Criteria

• Unwilling to give consent
• Injuries within the last 3 months
• Obesity, BMI above 30
• Bariatric surgery
• Cystic fibrosis, celiac disease, Crohn's disease
• Metabolic diseases
• Drugs reducing cholesterol absorption, thiazide diuretics, glucocorticosteroids, anticonvulsants, calcium-containing preparations,
• Planned prolonged exposure to sunlight during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Traditional Vitamin D	Traditional Vitamin D	Daily oral dose of traditional vitamin D for 4 weeks
Liposomal Vitamin D	Liposomal Vitamin D	Daily oral dose of liposomal vitamin D for 4 weeks

Primary Outcome Measures

Name	Time	Method
Level of 25-hydroxycholecalciferol	Baseline, 2 weeks, 4 weeks	Comparison of the level of 25(OH)D3 achieved in the blood

Trial Locations

Locations (1)

Gdański Uniwersytet Medyczny; 🇵🇱 Gdańsk, Poland