Vitamin D Supplementation and and Glycemic Indexes
Effect of Vitamin D Treatment on Glucose Homeostasis and Metabolism in Lebanese Older Adults: a Randomized Controlled Trial
研究概览
详细说明
A low serum 25-hydroxyvitamin D [(25(OH) D)] concentration was shown to correlate with higher fasting blood glucose (FBG) and insulin levels. Since age affect insulin sensitivity and the metabolism, we aimed in this randomized controlled trial to investigate the effect of vitamin D supplementation on glucose homeostasis and index of insulin resistance in elderly subjects living in Beirut, Lebanon.
Participants (n= 115) deficient in vitamin D were randomly divided into two groups, a group receiving 30,000 IU cholecalciferol/week for a period of 6 months, and a placebo group. The index of insulin resistance HOMA (homeostasis model assessment) was the primary outcome. Glucose homeostasis and metabolic markers were also measured at start of treatment and at 6 months.
研究类型
注册 (实际的)
阶段
- 不适用
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:
-Deficiency in vitamin D and having no medical history of type 2 diabetes mellitus
Exclusion Criteria:
patients with a history of type-2-diabetes, congestive heart failure, liver failure, renal failure, cancer, or taking oral hypoglycemic drugs or statin therapy, or patients having metabolic bone disease.
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Vitamin D group
The vitamin D group received three times per week a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada)
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安慰剂比较：Placebo group
The placebo group received three times per week a tablet containing microcrystalline cellulose (66.3%), starch (33.2%), and magnesium stearate (0.5%), per serving.
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Placebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%)
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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 |
|---|---|---|
|
HOMA-IR
大体时间：6 months
|
The HOMA-IR formula was as following: HOMA-IR = [insulin (mU/L) × glucose (mg/dL)]/22.5
where IR is the mutual of percentage sensitivity with a normal value of 1.0.
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6 months
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25 (OH)D
大体时间：6 months
|
Vitamin D
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
低密度脂蛋白胆固醇
大体时间：6个月
|
低密度脂蛋白胆固醇
|
6个月
|
|
BMI
大体时间：6 months
|
Body mass Index
|
6 months
|
|
FBG
大体时间：6 months
|
Fasting blood glucose
|
6 months
|
|
FBI
大体时间：6 months
|
Fasting Blood inslin
|
6 months
|
|
HbA1C
大体时间：6 months
|
Glycated hemoglobin
|
6 months
|
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Total cholesterol
大体时间：6 months
|
Total cholesterol
|
6 months
|
|
HDL cholesterol
大体时间：6 months
|
HDL cholesterol
|
6 months
|
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 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
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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