Treatment of Obesity With Vitamin D (40.000 IE Per Week for 1 Year)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
The purpose of the study is to evaluate if supplementation with vitamin D in doses of 20.000IU per week and 40.000 IU per week will result in weight loss in obese subjects as compared to placebo during 1 year.
详细描述
We will include 450 obese subjects that will be devided in 3 groups: 40.000IU cholecalciferol per week, 20.000 IU cholecalciferol per week, and placebo. All subjects will be given 500 mg calcium per day. There will be visits every tird month. In addition to weight reduction, we will also evaluate the calcium metabolism (blood test and urin samples), insulin sensitivity, muscle strenght, blood pressure and depression.
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
- Double
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 30 - 40
- •serum calcium < 2.55 mmol/L
排除标准
- •serious diseases
- •reduced kidney function
- •renal stone disease
- •using psychopharmaca
- •using drugs for weight reduction
结局指标
主要结局
Body Weight
Body composition
Measures of calcium metabolism
Insulin sensitivity
Muscle strength
Depression score
Blood pressure
次要结局
未报告次要终点