Placebo Controlled Pilot Study on Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes on Immunological, Endocrine and Metabolic Parameters: Step 2 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
- 31
- 试验地点
- 1
- 主要终点
- Increase and function of regulatory T-cells
研究概览
简要总结
In this placebo controlled study the investigators aim to investigate the effects of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.
详细描述
This is a bicentric, randomized placebo controlled, double blind study, with the aim to evaluate the effect of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.
The primary study goal is to evaluate the influence of vitamin D supplementation on the number and function of the master regulatory T-cells under controlled conditions within 13 months. The secondary study goals are a comprehensive immune phenotyping to determine whether Vit D produces changes consistent with a general improvement in immune homeostasis that supports ß-cell tolerating interventions, the assessment of ß-cell function in all subjects to obtain preliminary data on the effects of Vit D on ß-cell survival.
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
- 6 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males or females > 6 years
- •new onset of type 1 diabetes (3 months)
排除标准
- •pregnancy
- •hypercalcemia (>2,65 mmol/L)
- •chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)
研究组 & 干预措施
Placebo
peanut oil
干预措施: Cholecalciferol (Drug)
Vitamin D (Oleovit®)
cholecalciferol
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Increase and function of regulatory T-cells
时间窗: 13 months
The level and function of the regulatory T-cells will be compared between the two groups.
次要结局
- Calcium levels(13 months)
- Immunophenotyping(13 months)
- Insulin secretion(13 months)