The Study of Outpatient Ketogenic Diet on Seizure Rate, Nutritional Status and Some Biochemical Factors in Children and Adolescent With Refractory Epilepsy.
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- seizure rate
研究概览
简要总结
This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Investigators enroll a group of eligible epileptic children and adolescent who have been referred from epilepsy center to our clinic and prescribe them ketogenic diet.
详细描述
This research will be done to observe efficacy, safety, and tolerability of the classic ketogenic diet (CKD) on an outpatient basis without fasting, caloric and fluid restriction in children with and adolescents with intractable epilepsy.
30 children and adolescents with intractable epilepsy based on inclusion and exclusion criteria have been enrolled in the study, Investigators prescribe them classic ketogenic diet. Efficacy of the diet will be assessed through seizure rates, number of anti-epileptic drug used by the patients, and EEG changes. Seizure frequency will be assessed by seizure record diary that is filled out by family of the patients and will be compared with data that will be taken at 1, 3 months after start of the diet. EEG will be taken at baseline and 3 months after start of the diet. Patients will be reviewed at 1, 3 months after start of the diet at outpatient clinic. Intolerances and Complications will be documented at each clinic visits and via telephone calling during clinic visits intervals to evaluate tolerability and safety of the KD. For close monitoring of the complications along with blood tests and urinalysis Investigators will do echocardiography and renal ultrasound at baseline and 3 months after start of the diet. Laboratory values will be assessed at baseline and 3 months after start of the diet. Also, nutritional status and growth of children will be assessed at baseline and 1, 3 months after start of diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 1-18 years,
- •The patient has tried at least 3 different AED:s including one combination with two or more different AED:s.
- •The parents are willing to include their child in the study after written and verbal information.
- •Patients with all types of epilepsy can be included.
- •The patient is submitted to our epilepsy center.
排除标准
- •The patient has a medical condition, for example a metabolic disease, where ketogenic diet is contraindicated.
- •The patient's nutritional status is not good enough or intake of fluid is to small to permit treatment with ketogenic diet.
- •No history of hyperlipidemia
- •No history of renal stones
- •No previous treatment with ketogenic diet
- •Beta-oxidation defects - medium-chain acyl dehydrogenase deficiency (MCAD), long-chain acyl dehydrogenase deficiency (LCAD), short-chain acyld dehydrogenase deficiency (SCAD), long-chain 3-hydroxyacyl-coenzyme A (CoA) deficiency, and medium-chain 3- hydroxyacyl-CoA deficiency.
- •The family is expected to have compliance problems with treatment and/or seizure registration
结局指标
主要结局
seizure rate
时间窗: 3 months
The information will be obtained through seizure diary
次要结局
- Height(Before and after 1 and 3 months on the classical KD.)
- serum Triglyceride(Before and after 3 months on the classical KD)
- Investigating side effects(After 3 months on the classical KD)
- Weight(Before and after 1 and 3 months on the classical KD.)
- serum Cholesterol,(Before and after 3 months on the classical KD)
- serum LDL-Cholesterol(Before and after 3 months on the classical KD.)
- serum HDL-Cholesterol(Before and after 3 months on the classical KD)