NCT03233295已完成4 期
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 主要终点
- serum 25(OH)D concentration
研究概览
简要总结
A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in adults with Vitamin D Deficiency
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with vitamin D deficiency
排除标准
- •Subjects who experienced a hypersensitivity to the cholecalciferol
- •Subjects with Hypercalcemia
- •Subjects with Hypercalciuria
- •Subjects with renal impairment
- •Subjects with calcium stone
- •Subjects diagnosed with sarcoidosis or pseudo-hypoparathyroidism
- •Subjects who are to take vitamin D supplements during the study period
研究组 & 干预措施
Vitamin D deficiency
Experimental
干预措施: Vitamin D3 B.O.N. Injection (Drug)
结局指标
主要结局
serum 25(OH)D concentration
时间窗: 12 months
次要结局
- serum 1,25(OH)2D concentration(12 months)
研究者
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