Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin D3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Level of 25-hydroxycholecalciferol
研究概览
简要总结
The aim of the study was to compare the profiles of 25-hydroxyvitamin D serum concentration in healthy adults after 4 weeks of using vitamin D supplementation either in a liposomal or a traditional formulation.
详细描述
The study will be randomized, cross-over, participants will be randomly assigned to one of the study groups: A) the group receiving vitamin D3 in traditional formulation B) the group receiving vitamin D3 in liposomal formulation. The day before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation, participants will have their blood drawn. Then, after a wash-out period of 2 months, the groups will be switched. Participants will again receive daily supplementation with vitamin D3 for 4 weeks. Blood will be drawn before the start of supplementation (T0), 2 weeks (T1) and 4 weeks (T2) after the start of supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men, 18-60 years old.
- •Signed informed consent.
- •No injuries or hospitalizations within the last 3 months.
- •No vitamin D supplementation for the 2 months prior to the study initiation.
- •Refraining for the period of the clinical trial from consuming foods additionally fortified with vitamin D and dietary supplements containing vitamin D
- •Refraining for the period of the clinical trial from the use of cosmetic therapies that use prolonged body illumination
排除标准
- •Unwilling to give consent
- •Injuries within the last 3 months
- •Obesity, BMI above 30
- •Bariatric surgery
- •Cystic fibrosis, celiac disease, Crohn's disease
- •Metabolic diseases
- •Drugs reducing cholesterol absorption, thiazide diuretics, glucocorticosteroids, anticonvulsants, calcium-containing preparations,
- •Planned prolonged exposure to sunlight during the study period
结局指标
主要结局
Level of 25-hydroxycholecalciferol
时间窗: Baseline, 2 weeks, 4 weeks
Comparison of the level of 25(OH)D3 achieved in the blood
次要结局
未报告次要终点