Placebo Controlled Study to Assess the Effects of Vitamin D Supplementation on Parameters of the Immune, Endocrine and Metabolic System in Healthy Women and Men.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Increase and function of peripheral regulatory T-cells
研究概览
简要总结
In this placebo controlled study the investigators aim to investigate the effect of a 3 month vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy women and men. Vitamin D. In a pilot study the investigators showed an increase of certain immune cells, which regulate immunotolerance, the investigators therefore try to confirm these results with a placebo group. Furthermore the investigators assess the effect of vitamin D on the glucose metabolism and hormone levels.
详细描述
This is a randomized double-blind placebo controlled trial, with the aim to investigate the effect of a Vitamin D supplementation on parameters of the immune, endocrine and metabolic system in healthy humans without diabetes and obesity.
The primary aim is to assess the effect of vitamin D supplementation of the number and function of peripheral regulatory T-cells (Tregs). The investigators will measure the Tregs at baseline and monthly for 3 months. Furthermore the investigators assess additional immune cells from the adaptive immunosystem.
Furthermore the investigators will perform a standard mixed meal tolerance test at baseline and 3 months following the supplementation in order to assess the insulin secretion in vivo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 10 years
- •healthy subjects without chronic disease
排除标准
- •Hypercalcemia >2,65 mmol/L
- •pregnancy and lactation period
- •acute infections
- •chronic disease requiring treatment
研究组 & 干预措施
Cholecalciferol
干预措施: Cholecalciferol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Increase and function of peripheral regulatory T-cells
时间窗: 3 months
The level and function of the regulatory T-cells will be compared between the two groups.
次要结局
- immunophenotyping(3 months)
- Renin and aldosterone concentrations(3 months)
- Insulin secretion(3 months)
- calcium levels(3 months)