Pharmacokinetics Evaluation of Different Vitamin D3 Formulations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Evaluation of Vitamin D serum level: change of 1,25-Dihydroxyvitamin D
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluation of Vitamin D serum level: change of 1,25-Dihydroxyvitamin D
时间窗: 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).
Venous blood samples are collected to measure concentrations of 1,25-Dihydroxyvitamin D
Evaluation of Vitamin D serum level: change of 25-Hydroxyvitamin D
时间窗: 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).
Venous blood samples are collected to measure concentrations of 25-Hydroxyvitamin D
次要结局
- Safety blood work evaluation - change of gamma-glutamyl transferase (GGT)(at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).)
- Safety blood work evaluation - change of mineral levels such as calcium(at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).)
- Safety blood work evaluation - change of aspartate aminotransferase (AST)(at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).)
- Safety blood work evaluation - change of alkaline phosphatase(at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).)
- Safety blood work evaluation - change of bilirubin(at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).)
- Safety blood work evaluation - change of alanine aminotransferase (ALT)(at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).)
- Safety blood work evaluation - change of C Reactive Protein (CRP)(at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).)
- Safety blood work evaluation - change of mineral levels such as sodium(at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).)
- Safety blood work evaluation - change of mineral levels such as magnesium(at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).)
- Safety blood work evaluation - change of creatinine(at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).)
- Safety blood work evaluation - change of mineral levels such as phosphate(at day 0 (before treatment), at day 30 (end of treatment), at day 60 (after treatment).)