Pilot Study to Assess the Effects of Vitamin D Supplementation on the Number of Regulatory FoxP3+ T Cells in the Gastrointestinal Mucosa in Healthy Women and Men: Step 3 in the Austrian Diabetes Prevention Programme
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Increase of regulatory FOXP3+ T cells
研究概览
简要总结
In this pilot study the investigators aim to investigate the effects of vitamin D supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.
详细描述
This is a monocentric, open pilot study, with the aim to evaluate the effect of vitamin d supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.
The primary goal is to evaluate the influence of vitamin D supplementation on the regulatory FoxP3+ T cells in the gastrointestinal mucosa under controlled conditions within 2 months.
The secondary study goals are to evaluate the effect of vitamin D supplementation on peripheral induced tregs and on other important immune cells in the tissue (NK, NKT cells and LPCD) and in the blood (NK, NKT cells, Th17, Th1, Th2 cells) within 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-40 years
- •non smoker
- •BMI: 20-30 kg/m²
排除标准
- •hypercalcemia > 2,65 mmol/L
- •pregnancy
- •chronic diseases
研究组 & 干预措施
Cholecalciferol
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Increase of regulatory FOXP3+ T cells
时间窗: 2 months
the effects of vitamin D on regulatory FOXP3+ T cells will be measured at basal and after 2 months
次要结局
- other immune cells in the gastrointestinal mucosa(2 months)
- serum calcium level(2 months)