Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3

NCT ID: NCT06010121

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-17

Study Completion Date

2023-06-06

Brief Summary

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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

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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.

Conditions

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Bioavailability of Vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Liposomal Vitamin D

Daily oral dose of liposomal vitamin D for 4 weeks

Group Type EXPERIMENTAL

Liposomal Vitamin D

Intervention Type DIETARY_SUPPLEMENT

2000 IU of cholecalciferol in liposomal formulation

Traditional Vitamin D

Daily oral dose of traditional vitamin D for 4 weeks

Group Type ACTIVE_COMPARATOR

Traditional Vitamin D

Intervention Type DIETARY_SUPPLEMENT

2000 IU of cholecalciferol in traditional formulation

Interventions

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Liposomal Vitamin D

2000 IU of cholecalciferol in liposomal formulation

Intervention Type DIETARY_SUPPLEMENT

Traditional Vitamin D

2000 IU of cholecalciferol in traditional formulation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AronPharma Sp. z o. o.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gdański Uniwersytet Medyczny

Gdansk, , Poland

Site Status

Countries

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Poland

Other Identifiers

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02-AP-VD

Identifier Type: -

Identifier Source: org_study_id

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