NCT02158143已完成不适用
A Single High-dose Oral Supplement of Vitamin D in Young Chinese
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Effect of vitamin D3 supplementation on serum 25(OH)D changes
研究概览
简要总结
evaluated the effect and safety of a single high dose of cholecalciferol in Chinese young people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, younger, Chinese Hans aged from 25-35 years, including 25 and 35 years;
- •haven't taken vitamin D supplement for the past 6 months;
- •with a normal BMI (18-25 kg/m2);
- •with baseline serum 25(OH)D < 30 ng/ml;
- •be willing to follow the instruction and complete the study.
排除标准
- •clinically diagnosed cardiovascular disease, gastrointestinal disease, endocrine, blood, liver, lung, kidney, nerve or mental illness;
- •self-reported current use of any dietary supplements containing vitamin D within the 6 months before enrollment;
- •Severe anemia (hemoglobin concentration < 70 g/L);
- •Serum 25(OH)D ≥ 30 ng/mL at enrollment;
- •participating in other research studies within the 3 months before enrollment;
- •history of drug dependence or drug abuse;
- •History of heavy drinking (drinking 14 cups or more per week, equivalent to 360 mL beer or 150 mL white wine or 45 mL liquor per cup) and smokers (more than 10 cigarette per day);
- •clinical abnormal of blood biochemistry, hematology or urine laboratory values;
- •current pregnancy or lactation.
结局指标
主要结局
Effect of vitamin D3 supplementation on serum 25(OH)D changes
时间窗: within 140 day after supplementation
Effect of vitamin D3 supplementation on serum PTH
时间窗: within 140 day after supplementation
Effect of vitamin D3 supplementation on serum calcium
时间窗: within 140 day after supplementation
Effect of vitamin D3 supplementation on serum creatinine
时间窗: within 140 day of supplementation
Effect of vitamin D3 supplementation on urinary calcium / creatinine
时间窗: within 140 day after supplementation
次要结局
- Effect of vitamin D3 supplementation on serum lipids(within 140 day after supplementation)
- Effect of vitamin D3 supplementation on fasting blood glucose(within 140 day after supplementation)
研究者
Hui Wang
Principal Investigator
Chinese Academy of Sciences
研究点 (1)
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