The Effect of Vitamin D and Calcium Supplementation on the Prevention of Stress Fractures in Chinese Recruits.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Stress fracture
研究概览
简要总结
The main objective of this study is to find whether supplemental vitamin d and calcium can reduce the incidence of stress fractures in recruits. These high-risk recruits undergo intensive training which elevated bone turnover, which requires adequate level of vitamin D and calcium in order to support bone health. It is hypothesized that supplemental vitamin d and calcium will decrease the occurrence of stress fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recruits newly enlisted at a training base in September
- •Agree to accept relevant inspections and serological research, and sign an informed consent form.
排除标准
- •Suffer from diabetes, osteomyelitis and other diseases.
- •Suffer from claustrophobia and other MRI examination contraindications.
- •Long-term use of glucocorticoids, non-steroidal anti-inflammatory drugs or calcium, vitamin D.
- •A history of kidney disease.
- •Allergic to any ingredient of the medicine.
研究组 & 干预措施
Experimental (Treatment) Group
Oral vitamin D1000IU, 1/day, calcium 1200mg, 1/day, for 8 weeks.
干预措施: Vitamin D, Calcium (Drug)
Control Group
Oral placebo, for 8 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Stress fracture
时间窗: 3 months after the start of the basic military training.
Stress fractures were recorded when recruits reported to the clinic with suspected symptoms. All stress fractures were confirmed with radiography or Magnetic Resonance Imaging(MRI). Each subject with a stress fracture was recorded.
次要结局
未报告次要终点