Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 主要终点
- Clinical episodes of UVI treated by antibiotics
研究概览
简要总结
After spinal cord injury, patients have frequent urinary tract infections (UVI). Vitamin C is usually prescribed to prevent such infection, but the efficacy of the treatment is poorly documented. In the study, patients will be randomised either to receive vitamin C daily, or not, for one year, and clinical episodes of UVI will be registered. The null hypothesis is that vitamin C will not reduce the number of UVI episodes by 30%.
详细描述
The study is an investigator-blind randomised parallel study on the efficacy of vitamin C to prevent urinary tract infections in stable, ambulatory spinal cord-injured patients. To be included, patients should have had at least 3 previous UVI episodes over the last two years. 40 patients are included. Patients are randomised to receive either 1 g vitamin C b.i.d. over 1 year, or no vitamin C. The main outcome is the number of clinical UVIs that have been treated with antibiotics.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •spinal cord injury
- •3 or more episodes of UVI over previous 2 years
排除标准
- •pregnancy
- •continuous use of antibiotics, hippuric acid or crane berry juice
研究组 & 干预措施
1 vitamin C
Vitamin C 1g bid
干预措施: vitamin C (Drug)
结局指标
主要结局
Clinical episodes of UVI treated by antibiotics
时间窗: one year
次要结局
- Silent bacteriuria(one year)