Bioavailability of Vitamin D
Conditions
Keywords
Liposovit-D, Vitamin D, Cholecalciferol
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.
Interventions
DIETARY_SUPPLEMENTLiposomal Vitamin D
2000 IU of cholecalciferol in liposomal formulation
DIETARY_SUPPLEMENTTraditional Vitamin D
2000 IU of cholecalciferol in traditional formulation
Sponsors
AronPharma Sp. z o. o.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of 25-hydroxycholecalciferol | Baseline, 2 weeks, 4 weeks | Comparison of the level of 25(OH)D3 achieved in the blood |
Countries
Poland
Outcome results
None listed