Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes
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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Graz、奥地利
- Medical University Graz
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- males or females > 6 years
- new onset of type 1 diabetes (3 months)
Exclusion Criteria:
- pregnancy
- hypercalcemia (>2,65 mmol/L)
- chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Placebo
peanut oil
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weekly dose (based on 70 IU/kg bodyweight/day) orally
其他名称：
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有源比较器：Vitamin D (Oleovit®)
cholecalciferol
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weekly dose (based on 70 IU/kg bodyweight/day) orally
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Increase and function of regulatory T-cells
大体时间：13 months
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The level and function of the regulatory T-cells will be compared between the two groups.
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13 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Immunophenotyping
大体时间：13 months
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The effect of vitamin D on circulating immune cells and cytokine secretion at basal, after 3, 6 and 12 months.
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13 months
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Insulin secretion
大体时间：13 months
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Insulin secretion assessed with a mixed meal tolerance test will be performed basal, after 3, 6 and 12 months.
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13 months
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Calcium levels
大体时间：13 months
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Serum calcium levels will be measured basal, after 1,3,6,9 and 12 months.
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13 months
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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