Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial
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
- The incidence of DM
研究概览
简要总结
Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established.
The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk individuals.
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
- 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
- •Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l
- •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 granulomatus conditions, liver disease, kidney disease, or diabetes
- •Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications.
排除标准
- 未提供
研究组 & 干预措施
Vitamin D3
Vitamin D3 5000 IU daily
干预措施: Vitamin D3 (Drug)
Placebo
Placebo daily
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence of DM
时间窗: 2 years
Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.
次要结局
- incidence of hypercalcemia(2 years)
- incidence of hypercalciuria(2 years)
- area under the curve of 25 OH vitamin D level(2 years)
- fasting insulin to glucose ratio(2 years)
- slope of fasting glucose level(2 years)
- slope of 2-hour post challenge glucose level(2 years)
- area under the curve of BP(2 years)
- area under the curve of weight(2 years)
- time to develop DM(2 years)
研究者
Muhammad Maher Hammami
Chairman, Department of Clinical Studies & Empirical Ethics
King Faisal Specialist Hospital & Research Center