Vitamin D Clinical Trial
Official title:
Pharmacokinetics Evaluation of Different Vitamin D3 Formulations
Verified date | September 2023 |
Source | Factors Group of Nutritional Companies Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | April 30, 2023 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: - age between 21 and 65 years; avoid consumption of any additional food supplements containing vitamin D; avoid use of tanning beds or other artificial UVB sources. Participants must complete an online questionnaire on their medical history, weight, height, lifestyle (smoking, exercising etc.) and dietary habits relating to food rich in vitamin D, including other dietary supplementations. Exclusion Criteria: - use of vitamin D, calcium, magnesium, fish oil, or omega 3 fatty acids supplements; history of acute or chronic illness (such as gastrointestinal, liver and kidney disorders, osteoporosis …); pregnancy or lactation. |
Country | Name | City | State |
---|---|---|---|
Canada | Natural Factors | Coquitlam | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Factors Group of Nutritional Companies Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of Vitamin D serum level: change of 1,25-Dihydroxyvitamin D | Venous blood samples are collected to measure concentrations of 1,25-Dihydroxyvitamin D | at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment). | |
Primary | Evaluation of Vitamin D serum level: change of 25-Hydroxyvitamin D | Venous blood samples are collected to measure concentrations of 25-Hydroxyvitamin D | at day 0 (before treatment), at day 5, 10, 15 (during treatment), at day 30 (end of treatment), at day 45 and 60 (after treatment). | |
Secondary | Safety blood work evaluation - change of aspartate aminotransferase (AST) | Venous blood samples are collected to measure concentrations of AST | at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment). | |
Secondary | Safety blood work evaluation - change of alanine aminotransferase (ALT) | Venous blood samples are collected to measure concentrations of ALT | at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment). | |
Secondary | Safety blood work evaluation - change of alkaline phosphatase | Venous blood samples are collected to measure concentrations of alkaline phosphatase | at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment). | |
Secondary | Safety blood work evaluation - change of bilirubin | Venous blood samples are collected to measure concentrations of total bilirubin | at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment). | |
Secondary | Safety blood work evaluation - change of gamma-glutamyl transferase (GGT) | Venous blood samples are collected to measure concentrations of GGT | at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment). | |
Secondary | Safety blood work evaluation - change of creatinine | Venous blood samples are collected to measure concentrations of creatinine | at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment). | |
Secondary | Safety blood work evaluation - change of C Reactive Protein (CRP) | Venous blood samples are collected to measure concentrations of CRP | at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment). | |
Secondary | Safety blood work evaluation - change of mineral levels such as calcium | Venous blood samples are collected to measure concentrations of calcium | at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment). | |
Secondary | Safety blood work evaluation - change of mineral levels such as magnesium | Venous blood samples are collected to measure concentrations of magnesium | at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment). | |
Secondary | Safety blood work evaluation - change of mineral levels such as phosphate | Venous blood samples are collected to measure concentrations of phosphate | at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment). | |
Secondary | Safety blood work evaluation - change of mineral levels such as sodium | Venous blood samples are collected to measure concentrations of sodium | at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment). |
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