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Pharmacokinetics Evaluation of Vitamin D Formulations
The primary objective of this study is to evaluate plasma concentrations of Vitamin D (25-hydroxyvitamin D; 1,25-dihydroxyvitamin D) of different Vitamin D formulations in healthy volunteers at two concentrations. Pharmacokinetic parameters (Serum 25(OH)D and 1,25(OH)2D ng/ml) are compared with those of a regular Vitamin D formulation and a new (microencapsulated) LipoMicel Vitamin D formulation. The secondary objective of this study is to evaluate safety blood parameters- The following blood parameters (serum levels) are checked: Alkaline Phosphatase, ALT, AST, Bilirubin, CRP, Creatinine, GGT. In addition, mineral levels-such as calcium, magnesium and phosphorus, potassium and sodium-are measured before and at the end of the study.
Details
| Lead sponsor | Factors Group of Nutritional Companies Inc. |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 37 |
| Start date | Sat Jan 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sun Apr 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Vitamin D
Interventions
- Vitamin D3
Countries
Canada