Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3

Study Overview
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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.

Official Title
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Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3

Conditions
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Bioavailability of Vitamin D

Intervention / Treatment
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* Dietary Supplement: Liposomal Vitamin D
* Dietary Supplement: Traditional Vitamin D


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Vitamin D<br>Daily oral dose of liposomal vitamin D for 4 weeks | Dietary Supplement: Liposomal Vitamin D<br>* 2000 IU of cholecalciferol in liposomal formulation<br>|
| Active Comparator: Traditional Vitamin D<br>Daily oral dose of traditional vitamin D for 4 weeks | Dietary Supplement: Traditional Vitamin D<br>* 2000 IU of cholecalciferol in traditional formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of 25-hydroxycholecalciferol | Comparison of the level of 25(OH)D3 achieved in the blood | Baseline, 2 weeks, 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liposovit-D, Vitamin D, Cholecalciferol