Pharmacokinetics Evaluation of Vitamin D Formulations
Condition: Vitamin D
Study type: Interventional

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.
    

Detailed 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 speciﬁc procedure will be carried out.

      All tested products are formulation manufactured by Factors Group.
    

Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention description(s): Participants are randomly divided into 4 groups. The first group receives regular Vitamin D3 (1000IU), the second receives microencapsulated D3 (1000IU), the third group receives regular Vitamin D3 (2500IU), the fourth receives microencapsulated D3 (2500 IU). Plasma concentrations of Vitamin D (D3, 25(OH)D3 and D2) are measured at baseline-before treatment start (day 0), during treatment (day 14) 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.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel, randomized blinded study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment