Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3

Sponsor

AronPharma Sp. z o. o. (Industry)

Overall Status

Completed

CT.gov ID

NCT06010121

Collaborator

(none)

Enrollment

Location

Arms

3.6

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bioavailability of Vitamin D	Dietary Supplement: Liposomal Vitamin D Dietary Supplement: Traditional Vitamin D	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3

Actual Study Start Date :

Feb 17, 2023

Actual Primary Completion Date :

Jun 6, 2023

Actual Study Completion Date :

Jun 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liposomal Vitamin D Daily oral dose of liposomal vitamin D for 4 weeks	Dietary Supplement: Liposomal Vitamin D 2000 IU of cholecalciferol in liposomal formulation
Active Comparator: Traditional Vitamin D Daily oral dose of traditional vitamin D for 4 weeks	Dietary Supplement: Traditional Vitamin D 2000 IU of cholecalciferol in traditional formulation

Arm

Intervention/Treatment

Experimental: Liposomal Vitamin D

Daily oral dose of liposomal vitamin D for 4 weeks

Dietary Supplement: Liposomal Vitamin D

2000 IU of cholecalciferol in liposomal formulation

Active Comparator: Traditional Vitamin D

Daily oral dose of traditional vitamin D for 4 weeks

Dietary Supplement: Traditional Vitamin D

2000 IU of cholecalciferol in traditional formulation

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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