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Clinical Trial Summary

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.


Clinical Trial Description

Study Design: At least 40 healthy volunteers of both sexes in the age range 21-65 participate in a parallel, randomized blinded study conducted with different vitamin D3 products. Each treatment is administered orally per day at a total dose of 1000 UI and 2500 IU vitamin d3 (cholecalciferol), together with breakfast, over a period of 30 days. Participants are randomly divided into 4 groups (at least 10 per group): The first group receives regular Vitamin D (1000IU), the second receives microencapsulated D3 (1000IU), the third group receives regular Vitamin D (2500IU), the fourth receives microencapsulated D3 (2500 IU). Plasma concentrations (serum levels) of Vitamin D (25(OH)D and 1,25(OH)2D ng/ml are measured at baseline-before treatment start (day 0), during treatment (day 5, 10 and 15; one blood collection per day) and at end of treatment (day 30). After the end of supplementation, blood vitamin D concentrations are checked again at day 45 and day 60. The entire study session will span the course of 60 days. Participants are asked to attend 7 visits at LifeLabs to collect venous blood samples. Each Vitamin D treatment is consumed with a glass of water along with breakfast for a period of 30 days. Safety blood work is performed upon study enrolment, at the end of the Vitamin supplementation (day 30)- and at the end of the study (day 60) at Life Labs. The following blood parameters are checked and must be within normal ranges to participate the study: Alkaline Phosphatase, ALT, AST, Bilirubin, CRP, Creatinine, GGT. Mineral levels-such as calcium, magnesium and phosphorus-are measured before and at the end of the study (day 30). All participants must understand written and spoken English and give written informed consent before any study speciļ¬c procedure will be carried out. All tested products are formulation manufactured by Factors Group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05209425
Study type Interventional
Source Factors Group of Nutritional Companies Inc.
Contact Julia Solnier, Dr.
Phone +1 604-415-4185
Email [email protected]
Status Recruiting
Phase N/A
Start date January 1, 2022
Completion date March 2023

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