NCT02443246已完成3 期
A Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate 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
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Primary Efficacy Endpoints (serum 25(OH)D concentration)
研究概览
简要总结
To compare the efficacy of Vitamin D3 B.O.N. Intramuscular Injection within 12 weeks with that of placebo in adults with Vitamin D Deficiency.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 renal impairment
- •Subjects with Hypercalcemia
- •Subjects with Hypercalciuria
- •Subjects with clinically doubted calcium stone
- •Subjects diagnosed with sarcoidosis
- •Subjected diagnosed with pseudo-hypoparathyroidism
- •Subjected with malignancy
- •Subjects with clinically significant cardiovascular or lung impairment Judged by the investigator
- •Subjects with the below laboratory abnormality (Platelet, WBC, Absolute neutrophil count, Albumin, AST or ALT)
- •Subjects who are to take vitamin D supplements during the study period
研究组 & 干预措施
Vitamin D deficiency
Experimental
Group 1
干预措施: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU) (Drug)
Vitamin D deficiency
Experimental
Group 1
干预措施: Placebo (Drug)
Vitamin D deficiency (Low)
Experimental
Group 2
干预措施: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU) (Drug)
Vitamin D deficiency (Low)
Experimental
Group 2
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Efficacy Endpoints (serum 25(OH)D concentration)
时间窗: 12 weeks
serum 25(OH)D concentration
次要结局
- Secondary Efficacy Endpoints (serum 25(OH)D concentration)(24 weeks)
研究者
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