Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy - a Prospective Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Seizure frequency
研究概览
简要总结
The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children and adolescents with drug-resistant epilepsy regarding seizure control, and to create a protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway.
详细描述
The study is a prospective trial on the Modified Atkins Diet for children and adolescents with drug-resistant epilepsy. The Modified Atkins Diet is a less restrictive diet than the classical ketogenic diet, which is usually offered to this group of patients. Twenty patients between 2 and 18 years are included in the study, and the study period is 6 months. The study will be conducted at the National Centre for Child Epilepsy in Norway.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 2-18 years
- •At least 3 epileptic seizures per week
- •Tried at least two anti-epileptic drugs without satisfactory seizure control
- •Willing to try diet treatment for 6 months
排除标准
- •Too difficult for the family to adhere to a strict diet
- •Not able to fill in a seizure calendar
- •Local authorities will not approve the treatment
- •VNS stimulator the last 12 months or changes made to VNS stimulator during the last three months
- •Other disease where a diet high in fat is contra indicated
- •Diet treatment is not possible because of poor intake of food or fluids
- •Cortisol or other medication that influence energy metabolism or epileptic drug metabolism last month
- •Patient has the last month used alternative medicine which may influence the diet
- •Patient has tried the ketogenic fiet og Modified Atkins diet the last three years
- •pregnancy
结局指标
主要结局
Seizure frequency
时间窗: 6 months
Seizure frequency is assessed after 1 month, 3 months and 6 months.
次要结局
- Ambulatory EEG(After 6 months)
- Body Weight(6 months)
- Quality of life(6 months)
- Ketosis(6 months)
- Dietary records(10 weeks)