Comparison of the Effect of Low Glycemic Index Diet Compared to the Classical Ketogenic Diet in Reducing the Number of Seizures in Children With Drug Resistant Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Seizure reduction
研究概览
简要总结
Epilepsy is a common disease among children. Today, treating epilepsy remains a major challenge, with many children affected by this condition. According to reports, 30% of children with epilepsy do not respond well to treatment. Various methods are available for managing epilepsy, one of the most accepted therapies for this condition are dietary therapies. Numerous studies have shown that dietary therapy is an effective and can have reasonable response in treating seizure.
The most commonly used dietary intervention is the Classic Ketogenic Diet (CKD). In the CKD, approximately 90% of calories come from fat, making it a highly restrictive regimen that causes significant challenges for children to follow. Many studies have reported low adherence rates due to its difficulty, with a substantial number of patients discontinuing the diet over time.
Some studies have explored the use of the Low Glycemic Index Therapy(LGIT), another form of the ketogenic diet, in managing drug-resistant epilepsy can be successful. In the LGIT, 60% of energy is derived from fat, 30% from protein, and 10% from carbohydrates. Due to the reduced fat content and greater dietary flexibility, this diet has fewer side effects and is easier to follow. Studies have also shown higher adherence rates to LGIT compared to CKD.
Although limited research is available on LGIT, existing studies suggest that it may be as effective as CKD in treating epilepsy. Given the widespread prevalence and severe complications associated with untreated epilepsy in children, Further research into dietary therapies is crucial, as untreated epilepsy can lead to irreversible damage in children.
The aim of this study is to compare the effectiveness of the Low Glycemic Index therapy and the Classic Ketogenic Diet in epilepsy treatment. If LGIT proves to be as successful as CKD, it could be considered a suitable alternative for managing epilepsy.
In this randomized clinical trial, 40 children with drug-resistant epilepsy will be enrolled. Participants will be selected from patients referred by Pediatric Neurologists to dietitians for ketogenic diet therapy.
After obtaining informed consent, participants will be randomly assigned using a block randomization method to one of two groups: the LGIT group or the CKD group. At the end of three months, the two groups will be compared in terms of seizure frequency and duration using statistical tests. The effectiveness of LGIT relative to CKD will be reported.
详细描述
Epilepsy is a widespread neurological conditions in children. Recent estimates suggest that 1 in 418 children live with active epilepsy. Epilepsy can negatively impact a child's growth, learning, and development, leading to cognitive impairments, learning disabilities, developmental issues, and, in severe cases, death. Therefore, finding an effective treatment is necessary. Although many drugs have been developed for the treatment of epilepsy, one-third of patients still have drug-resistant epilepsy (DRE) that does not respond well to available epilepsy drugs.
According to the International League Against Epilepsy (ILAE), drug-resistant epilepsy(DRE) is defined as a condition in which, despite the use of at least two appropriate antiepileptic drugs at the correct dose, the epilepsy still persists and the patient continues to experience seizures.According to this definition, 30% of children with epilepsy suffer from DRE. DRE patients respond poorly to pharmacologic therapies and they need alternative therapies such as surgery, vagus nerve stimulation, and dietary therapy.
In 2018, an expert consensus committee suggested the ketogenic diet as a treatment for children with DRE based on the current scientific knowledge.In epilepsy dietary therapy, Ketogenic diet can be used. The ketogenic diet is an effective, non-invasive, and non-pharmacologic treatment for refractory childhood epilepsy. The ketogenic diet for epilepsy treatment has been used since the 1920s and in different articles. It had few to no neurotoxic effects compared to multiple anti-seizure medicines.
The ketogenic diet consists of four forms: Classic ketogenic diet, Low glycemic index therapy(LGIT), Modified Atkins diet(MAD), and MCT Ketogenic diet. According to clinical guideline of the National Institute for Health and Clinical Excellence (NICE), Ketogenic diet is a non-pharmacologic treatment for children with DRE. while the exact mechanism is still unclear, it has shown to be effective.
The classic Ketogenic diet (CKD) is usually described by the ratio of fat to carbs and protein. Mostly, a 4:1 CKD is prescribed but there are other forms like 3:1 and 2.5:1 CKD.
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
- Single (Outcomes Assessor)
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
- •Children between 2 and 18 years old who still have epilepsy despite receiving 2 or more medications
- •Children with genetic disease need to receive ketogenic diet (pyruvate dehydrogenase deficiency and GLUT-1 transporter deficiency)
排除标准
- •Parents' disapproval of the child's participation in the study Having liver and kidney diseases Doctor's disapproval based on the patient's condition Absolute contraindications to the ketogenic diet
结局指标
主要结局
Seizure reduction
时间窗: 3 Months
This study consists of two arms: CKD , which has been the standard therapy for many years, and LGIT , a newer type of Ketogenic diet that has shown similar results to CKD in several published studies. This study aims to evaluate whether LGIT is as effective as CKD while offering a more comfortable and palatable dietary option. All 40 participants in both arms will recieve diet for 3 months.Parents will monitor and report the impact of the dietary therapy on seizure frequency, classifying outcomes into one of four categories: 1. Seizure free:No seizures reported 2. More than 90% seizure reduction 3. More than 50% seizure reduction 4. Less than 50% seizure reduction Based on previous studies, a reduction of less than 50% is considered an unsuccessful therapy for epilepsy treatment using dietary therapy. After three months, all 40 participants will be evaluated to determine the effectiveness of each diet in treating epilepsy and results will be analyzed.
次要结局
未报告次要终点
研究者
Saman Sepehrar
Saman Sepehrar (MSc Student in Nutrition), supervised by Dr. Talebi, Pediatrician, PhD in Nutrition.
Mashhad University of Medical Sciences