NCT01170442终止3 期
Does Vitamin D Improve Glycemic Control in Type II DM? A Double Blind Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Area under the curve of HA1C.
研究概览
简要总结
Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. However, a cause-effect relationship between vitamin D deficiency and glycemic control has not been established. The investigators plan to conduct a double blind, randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic control in Type II DM.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type II diabetics living in Riyadh area who consume no more than one serving of milk/day
- •Do not take vitamin supplement
- •Habitually have less than 10 hour of sun exposure per week
- •Don't suffer from granulomatous conditions, liver disease, or kidney disease
- •Don't take anticonvulsants, barbiturates, or steroids.
- •Stable glycemic control (not more than 0.5% difference between current HA1c and a HA1c obtained 2-4 months earlier)
- •Current HA1c between 6.5 and 8%, and current total 25 OH vitamin D level between 10-30 nmol/L.
排除标准
- 未提供
研究组 & 干预措施
vitamin D3 2000 IU
Experimental
干预措施: vitamin D3 2000 IU (Drug)
vitamin D3 5000 IU
Experimental
干预措施: vitamin D3 5000 IU (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the curve of HA1C.
时间窗: 6 months
次要结局
- incidence of hypercalciuria(6 months)
- area under the curve of fasting blood glucose(6 months)
- fasting insulin to glucose ratio(6 months)
- area under the curve of weight(6 months)
- incidence of hypercalcemia(6 months)
- Area under the curve for BP(6 months)
- area under the curve of 2 hour post breakfast glucose(6 months)
- area under the curve for 25 OH vitamin D level(6 months)
研究者
Muhammad Maher Hammami
Chairman, Department of Clinical Studies & Empirical Ethics
King Faisal Specialist Hospital & Research Center
研究点 (1)
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