Vitamin D Supplement for Patients With Tibial Fracture Treated With an External Ring Fixator. A Prospective Randomized Double-blind Study.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Time of fracture healing
研究概览
简要总结
The purpose is to study:
- the frequency of vitamin D deficiency at patients with tibial fracture treated with an external ring fixator
- if vitamin D supplement facilitates fracture healing
- a possible relation between vitamin D deficiency and the risk of complications and the time of fracture healing
详细描述
External ring fixator is a widespread and well-known method to treate complex tibial fractures. The effect of treating proximal and distal intra-articulatio tibial fractures has been positive until now.
Complications such as malunions, nonunions, re-fractures and extended time of ring fixation will occur in 5-10% of all tibial fractures in patients treated with ring fixator. Factors like trauma of soft tissue, smoking and compromised afflux of blood are associated with a higher frequency of nonunion.
It has been documented that elderly people with hypovitaminosis D have a higher risk of being affected by osteoporosis and fractures. Furthermore, there is a possible association between the severity of fracture and hypovitaminosis. The time of fracture healing is also extended compared to fractures in patients who are not affected by osteoporosis.
Until now research has not shown whether the fracture healing process is influenzed by vitamin D.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with tibial fracture
- •A written signed statement of consent
- •All potential patients primary with osteosynthesis Iliazov
排除标准
- •Tumours in bone
- •Metastases to bone marrow
- •Chronic renal disease
- •Drug abuse
- •Abuse of alcohol (>21 drinks a week for men and > 14 drinks a week for women)
- •Morbus Cushing disease
- •Glandulae thyroid disease
- •Pregnancy
- •Chronic steroid therapy
- •Hepatic insufficiency
- •Sarcoidosis, tuberculosis or silocosis
- •Patients under 18 years
- •Inability to take medicine
- •Adverse effects of vitamin D or allergic to vitamin D
研究组 & 干预措施
Vitamin D3 cholecalciferol
1000IU x3 daily in a period of 14 days. After 14 days 1000IU x 1 daily.
干预措施: Vitamin D3 cholecalciferol (Drug)
Placebo orally everyday
One placebo pill x3 daily in a period of 14 days. After 14 days x1 placebo pill daily.
干预措施: Placebo orally everyday (Drug)
结局指标
主要结局
Time of fracture healing
时间窗: 20 weeks
Time of fracture healing, i.e. time from osteosynthesis until fracture healing is clinically and radiologically registered.
次要结局
- Vitamin D receptor DNA(20 weeks)
- Complications(20 weeks)