Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in seizure frequency
研究概览
简要总结
In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a treatment option for children up to 18 years.
We now initiate an open, prospective, randomized and controlled study with the aim to test the efficacy of treatment with modified Atkins diet in adults with focal and generalized epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients on a permanent basis.
详细描述
Poorly controlled epilepsy in adults affects health and quality of life in many ways. Within this heterogenous population there are individuals who are motivated for a very strict diet in order to reduce seizures.
Among adults with epilepsy 75 - 80 % are diagnosed with focal epilepsy, while 20 - 25 % have generalized onset of seizures.
We plan to include 92 patients with focal epilepsy diagnosis. Those are randomized into diet and control groups.
During the inclusion period we also treat patients with generalized epilepsy that qualify for participation, but these are not to be randomized, rather they will follow the diet group course. We assume 18 - 23 patients with generalized epilepsy will be included in the project.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Focal or generalized epilepsy diagnosis
- •More than 3 recordable seizures per month
- •BMI > 18,5
- •Not responded to at least three 3 AEDs
- •16 years or older
- •Motivated to complete the diet after thorough information
- •Capable of recording seizures
- •Capable of preparing the diet
排除标准
- •Hypercholesterolemia, cardiovascular disease or kidney disease
- •Been on modified Atkins diet for more than one week during the last year
- •Status epilepticus last six months
- •epilepsy surgery or VNS implant last year
- •4 weeks continuous seizure freedom last 2 months
- •PNES seizures
- •other disease where dietary treatment is contraindicated
- •usage of drugs or supplements that may interfere with diet or AED
- •being pregnant or planning pregnancy
研究组 & 干预措施
Modified Atkins diet treatment
12 weeks of Modified Atkins diet treatment, recording seizures
干预措施: Modified Atkins diet treatment (Other)
No intervention
12 weeks seizure record
结局指标
主要结局
Change in seizure frequency
时间窗: 12 weeks
All participants record detailed seizure records for 12 weeks prior to the control/diet period. The diet group participants are subsequently treated with modified Atkins diet for 12 weeks, while the control group continue their normal diet and record seizures for another 12 weeks. Seizure records for each participant before and during intervention are compared.
次要结局
- Change in standard 3-hrs EEG(12 weeks)
- Change in life quality measured by validated questionnaire(12 weeks)
- Change in body weight(12 weeks)
- Change in executive functions measured with validated questionnaire(12 weeks)
- Change in seizure strength and severity measured by validated questionnaire(12 weeks)
- Change in various blood and serum measures(12 weeks)
研究者
Magnhild Kverneland
Registered Nutritionist
Oslo University Hospital