Use of the Atkins Diet for Children With Sturge Weber Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Seizures
研究概览
简要总结
This research is being done to find out if the Atkins Diet can be used safely and effectively to reduce seizures in children who have Sturge Weber syndrome.
The ketogenic diet is a proven therapy for epilepsy, but can be difficult to use in children. The Atkins Diet is a high fat, high protein, low carbohydrate diet introduced in the 1970s to help with weight loss. It is different from the ketogenic diet in four major ways: no calorie restriction, no fluid restriction, no protein restriction, and is easy to start outside the hospital. People on the Atkins Diet become ketotic (produce high levels of ketones, a certain substance in the body), like patients on the ketogenic diet, and the investigators believe this may lead to seizure control.
Children aged 2-18 with Sturge Weber syndrome and seizures at least monthly, who have used at least two anti-seizure drugs may join. 5 children in total will be enrolled.
详细描述
If you agree to be in this study, we will ask you to do the following things:
Before the diet is started:
- We will ask you to keep track of your child's seizures daily for 2 weeks before starting the Atkins diet and provide us with a 3-day food record as well.
- Baseline blood (about 2 teaspoons) and urine work will be obtained.
- We will give you a free copy of a carbohydrate-counting guide.
- You will be asked to fill out a 3-day food record.
On the diet:
- Give your child a daily calcium supplement and multivitamin.
- Keep a daily seizure log.
- Check urine for ketones (to make sure the diet is working) and specific gravity (to make sure your child is well hydrated) twice a week and when you come to clinic.
- We will ask you to weigh your child at home every week, and we will weigh him or her when you come into clinic too.
- Do not fluid restrict your child; please give plenty of carbohydrate-free fluids.
- You will give 20 grams per day of carbohydrates. We will give you instructions on how to measure daily intake of carbohydrates.
- We will not change medications for the first three months. Do not change your child's seizure medicines without checking with our doctors.
- For the first three months, we ask you to avoid store-bought low-carbohydrate products (as they can have more carbohydrates than advertised).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •2-18 years
- •Sturge Weber syndrome
- •Monthly seizures (at least)
- •Tried at least two anticonvulsants
排除标准
- •Prior use of the Atkins or ketogenic diets
- •Patients with non-epileptic seizures (pseudoseizures) will be excluded
- •Patients that are pregnant or become pregnant during the study will be excluded
- •High cholesterol
结局指标
主要结局
Seizures
时间窗: 6 months
Seizure frequency will be compared to baseline (pre-Diet).
次要结局
- Ketosis(6 months)
- Safety (stroke like events)(6 months)