Ketogenic Diet Program for 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
- Change from baseline in the core symptoms of epilepsy (seizure frequency/severity)
研究概览
简要总结
This study will assess the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Two study groups will be comprised of children with epilepsy (0-18 years of age) and whether or not they receive the ketogenic diet - epilepsy/ketogenic diet and epilepsy/non-ketogenic diet.
详细描述
According to an evidence-based guideline on the diagnosis and management of epilepsy from the National Institute for Clinical Excellence (2012), the ketogenic diet may be considered as an adjunctive treatment in children with drug-resistant epilepsy. Vast anecdotal and Class 1 studies have confirmed that the ketogenic diet helps most children with intractable seizures and cures many. Dietary therapies for epilepsy (e.g., classic ketogenic diet) have been shown to be highly effective. For example, Lee (P.R.) and Kossoff reported that approximately 50% of children with drug-resistant epilepsy had a greater than 50% reduction in seizures within days to months of treatment. In addition, use of the ketogenic diet as a treatment for epilepsy has been shown to reduce the escalating costs associated managing poorly controlled seizures (e.g., decrease in outpatient and emergency visits, inpatient hospitalization, neuroimaging, electro-encephalography, lab testing, and medication use).
If a child's seizures continue after two to three seizure medications have been tried, the ketogenic diet should be considered. However, many parents still medicate their children well beyond these guidelines and tolerate seizure frequency because they have no other alternatives. Given the physical and emotional toll that recurring seizures exact upon these children/families, the potential for improvement with the ketogenic diet is substantial. However, the ketogenic diet remains unavailable to most children.
Approximately 1% of Hawaii's children are projected to have epilepsy, but there is no established, ketogenic diet program for them to receive this dietary intervention, which can incorporate culturally distinct foods to improve palatability and compliance. Although the ketogenic diet has shown promise for broadening the scope of therapeutic options for children with epilepsy, it requires further study in an ethnically diverse population. At Shriners Hospitals for Children-Honolulu, the investigators have initiated a ketogenic and related dietary (e.g., modified Atkins diet) intervention program for children with epilepsy and started to assess its efficacy in treating epilepsy/seizures. This program also includes educational seminars and services to patients residing on the other Hawaii islands through outreach trips. The investigators have begun to enroll children with epilepsy into two groups based on whether or not they receive the ketogenic diet - epilepsy/ketogenic diet and epilepsy/non-ketogenic diet; total estimate of 15-30 participants over three years. Based upon initial findings, the investigators will implement a comprehensive, multidisciplinary ketogenic diet program that will potentially reach hundreds of children throughout Hawaii, the Pacific Basin, and elsewhere.
Specific Aims:
Aim 1. To assess the therapeutic efficacy of the ketogenic diet on epilepsy/seizures.
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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 0-18 years.
- •Primary diagnosis of epilepsy.
- •Parent/legal guardian and child able to read or understand English, and able/willing to provide informed consent/assent.
- •Females of childbearing potential must have a negative pregnancy test result and agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the last dose of study drug - childbearing potential is defined a girls who are > Tanner stage 2 and urine pregnancy tests are acceptable.
排除标准
- •Known cardiac disorder including arrhythmias or hypertension.
- •Carnitine deficiency (primary).
- •Carnitine palmitoyltransferase (CPT) I or II deficiency.
- •Carnitine translocase deficiency.
- •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.
- •Pyruvate carboxylase deficiency.
- •Porphyria.
- •Inability to maintain adequate nutrition.
- •Patient or caregiver non-compliance.
研究组 & 干预措施
Epilepsy/Non-Ketogenic Diet
Children (0-18 years of age) diagnosed with epilepsy will not receive the ketogenic diet intervention.
Epilepsy/Ketogenic Diet
Children (0-18 years of age) diagnosed with epilepsy will receive the ketogenic diet intervention.
干预措施: Ketogenic Diet (Other)
结局指标
主要结局
Change from baseline in the core symptoms of epilepsy (seizure frequency/severity)
时间窗: Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet)
Assess the number of epileptic seizures through review/analysis of responses to the seizure log (self-report)
次要结局
- Change from baseline in the number of medications used for epilepsy management(Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet))
- Change from baseline in subject/family satisfaction with the ketogenic diet(Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet))
- Change from baseline in the dosage of medications used for epilepsy management(Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet))
- Change from baseline in the number of lab tests ordered for epilepsy management(Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet))
- Change from baseline in the number of emergency room or hospital visits for epilepsy management(Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet))
- Change from baseline in ketone levels due to the ketogenic diet(Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet))
- Change from baseline in biochemical profiles due to the ketogenic diet(Pre- and post-ketogenic diet intervention (at baseline, and after three and six months on the ketogenic diet))
研究者
Ryan Lee, MD
Director - Neurodevelopmental Clinic, Research
Shriners Hospitals for Children