Comparison of the Effectiveness of the Outpatient Classical Ketogenic Diet and Modified Atkins Diet on Seizures Frequency, Nutritional Status and Some Biochemical Factors in Children and Adolescents With Intractable Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Comparison of the efficacy of the outpatient classical ketogenic diet and modified atkins diet
研究概览
简要总结
Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients in each group, and will receive the diet for three months on non-randomised basis. In the classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be established on outpatient setting, without fasting and gradually. The modified Atkins diet will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of carbohydrate plus protein.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents age 1 to 18 years Have not responded well to at least two primary and one secondary antiepileptic drugs Have not received ketogenic diet therapy previously Absence of renal diseases history Absence of cardiovascular diseases history Absence of thyroid function disorders history Absence of cholesterol level more than 300 mg/dl and Triglyceride level more than 200 mg/dl Absence of inherited metabolic disorders that are contraindicated for ketogenic diet therapy including fatty acid oxidation disorders
排除标准
- •Onset of complications that threat the life of the patient Inability to continue the diet Unwillingness to adhere the diet
研究组 & 干预措施
Classical ketogenic diet
The classical ketogenic diet with 4:1 ketogenic ratio, each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced.
干预措施: Classical ketogenic diet (Other)
Modified Atkins diet
The modified Atkins diet with a ratio of 1 or 2 to 1 (1:1, 2:1), each 1 or 2 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.
干预措施: Modified Atkins diet (Other)
结局指标
主要结局
Comparison of the efficacy of the outpatient classical ketogenic diet and modified atkins diet
时间窗: Prior to and three months after initiation of the classical ketogenic diet and modified Atkins diet
次要结局
- Comparison of the nutritional status of children and adolescents on the classical KD and MAD(Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet)
- Comparison of the lipid profiles of children and adolescents on the classical KD and MAD(Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet)
- Comparison of the serum electrolytes levels of children and adolescents on the classical KD and MAD(Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet)