Use of the Atkins Diet for Adults With Intractable Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Seizure reduction
研究概览
简要总结
This is a prospective study to determine whether the Atkins diet reduces seizures, creates ketosis, and is well tolerated in adults with epilepsy. Approximately 30 patients will be enrolled, expecting 20 to complete the 6-month study. The investigators plan to establish the seizure baseline and type, initiate the Atkins diet, then monitor its administration in terms of seizure reduction, ketosis, and side effects for a 6-month period.
详细描述
Patients are seen in the Johns Hopkins General Clinical Research Center (GCRC) and started on a modified Atkins diet (15g/day of carbohydrates). Medications remain unchanged and labs are drawn. Followup is at 1 month, 3 months, and 6 months into the study. After 1 month, carbohydrates and medications can be altered. Ketosis (urine) is measured by patients semiweekly, weight weekly, and seizures daily and recorded on a calendar.
This study is ongoing with approximately 20 patients of 30 enrolled as of February 2006.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Ages 18 and over
- •Weekly seizures or 4 times per month
- •Use of at least 2 anticonvulsant drugs
排除标准
- •Prior use of the Atkins diet for > 1 week
- •Prior use of the ketogenic diet within the past year
- •Kidney, heart disease, renal disease
- •Hypercholesterolemia
- •Pseudoseizures
- •Pregnancy
- •Body mass index (BMI) below 18.5
- •Status epilepticus within the past 6 months
- •2 week seizure-free period within the past 6 months
结局指标
主要结局
Seizure reduction
次要结局
- Ketosis
- tolerability