Use of Sodium Bicarbonate to Alkalinize Serum/Urine in Pediatric Patients Treated With Topiramate (Pilot Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in measured urine parameters
研究概览
简要总结
Effect of oral sodium bicarbonate therapy on renal tubular acidosis in epilepsy patients taking topiramate.
详细描述
Children on topiramate are at a risk of renal tubular acidosis and subsequent development of renal stones. Sodium bicarbonate has been shown to reduce renal tubular acidosis in other populations. To date, no data exist on the efficacy of correction of renal tubular acidosis in pediatric patients on topiramate. We are proposing to investigate the efficacy of 4 weeks of oral sodium bicarbonate therapy to reduce tubular acidosis in patients on topiramate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with epilepsy receiving oral topiramate for a minimum of 3 months
排除标准
- •pre-existing renal impairments (ie nephropathy, primary nephritis)
- •receiving other medications or diet therapies that may influence renal function or urine acidity/ citrate concentration
研究组 & 干预措施
Control
Patients will not receive treatment if they do not have metabolic acidosis at baseline.
Sodium Bicarbonate
Patients will receive sodium bicarbonate for 4 weeks, based on pre-calculated weight based doses. Patients are selected if they have metabolic acidosis at baseline.
< 24 kg : 1/4 teaspoon bid. 24 - 42 kg : 1/2 teaspoon bid. > 42kg : 3/4 teaspoon bid.
干预措施: Sodium bicarbonate (Dietary Supplement)
结局指标
主要结局
Changes in measured urine parameters
时间窗: Baseline, then at 4 weeks
Spot urine sample will be tested for calcium, creatinine and citrate
次要结局
- Changes in measured blood parameters.(Baseline, then at 4 weeks)
- Changes in frequency of seizures.(Baseline, then at 4 weeks)
研究者
Mandeep Sidhu
Resident Physician
McMaster Children's Hospital