Vitamin D Supplementation to Patients With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- glycated hemoglobin
研究概览
简要总结
The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.
详细描述
The purpose of the study is to evaluate if supplementation with vitamin D in a dose of 40.000 IU per week will result in improved metabolic control in patients with type 2 diabetes.
We will include 70 patients with type 2 diabetes. They will be treated with 40.000 IU cholecalciferol per week (or placebo) for 6 months. Metabolic control will be evaluated with measurements of glycated hemoglobin, home glucose measurements, and fasting blod glucose and serum insulin. Only subjects using insulin at bedtime combined with metformin during the day will be included.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes for at least 1 year
- •age 21-75 years
- •long-acting insulin at bedtime
- •metformin during the day
- •for women of child bearing age use of reliable method of birth control
排除标准
- •serum creatinine above 130 umol/l for men and above 110 for women
- •systolic blood pressure > 175 or diastolic > 104 mmHg
- •heart disease
- •serum calcium > 2.54 mmol/l
- •history of renal stones
研究组 & 干预措施
1
干预措施: Cholecalciferol (vitamin D) (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
glycated hemoglobin
时间窗: 6 months
次要结局
- body weight(6 months)
- insulin sensitivity(6 months)
- lipids(6 months)
- blood pressure(6 months)
- Hip/waist ratio(6 months)
- Hs-CRP(6 months)