NCT01075022Unknown不适用
Effect of a Single Colecalciferol Dose on Insulin Resistance: A Prospective Randomized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Blood Glucose Level
研究概览
简要总结
A Prospective Double-Blinded, Placebo Controlled, Randomized Trial comparing a single dose of Vitamin D (Colecalciferol) 300.00UI to placebo on patients with insulin resistance. Primary Outcome: Blood glucose and homeostasis model assessment for insulin resistance (HOMA-R) after 90 days. Study hypothesis: Vitamin D treatment may improve insulin resistance and decrease glucose level, since there is an association between hypovitaminosis D and increased insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasten Blood Glucose > 100 mg/dL and < 126 mg/dL
- •Age > 18 years
排除标准
- •Diabetes Mellitus
- •Use of metformin
- •Vitamin D Use
- •Hypercalcemia
- •Chronic Hepatitis
研究组 & 干预措施
Vitamin D
Experimental
干预措施: Colecalciferol (Vitamin D3) 300.000 UI (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Blood Glucose Level
时间窗: Baseline and day 90
次要结局
- Blood Calcium Level(Baseline and day 90)
- HOMA-R(Baseline and day 90)
研究者
研究点 (1)
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