A Randomized, Open-label Evaluation of KetoCal® in Initial Combination With the Modified Atkins Diet for the Dietary Management of Intractable Adult Epilepsy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Ketosis
研究概览
简要总结
The modified Atkins diet (MAD) has been shown to be effective in treating children and adults with medically resistant seizures. A recent study in children showed that the use of KetoCal® once per day in addition to the MAD appeared to be beneficial when used during the first month. The investigators hypothesize that including a daily KetoCal® liquid tetrapak with one meal during the initial month of the MAD will produce urinary ketosis in more adult patients than the MAD alone and will lead to greater seizure reduction.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages >17 years.
- •At least weekly seizures (or 4 per month). All seizure types allowed.
- •Tried at least two anticonvulsants.
排除标准
- •Unwilling to restrict carbohydrates
- •Significantly underweight (Body Mass Index <18.5)
- •Prior use of the modified Atkins diet for ≥ 2 days
- •Prior use of KetoCal® at any time for any duration
- •Use of the ketogenic diet within the past year
- •Kidney disease
- •History of hypercholesterolemia (total cholesterol > 300 mg/dl) or hypertriglyceridemia (triglycerides > 200 mg/dl)
- •Metabolic or mitochondrial disorder
- •Pregnancy or breastfeeding
- •Lactose intolerance or milk allergy
- •Aversion to liquids or inability to eat solid food
研究组 & 干预措施
Modified Atkins diet plus KetoCal
Patients will receive the modified Atkins diet in combination with a KetoCal tetrapak daily for the first month. The second month, no tetrapaks will be given.
干预措施: Modified Atkins diet (Dietary Supplement)
Modified Atkins diet plus KetoCal
Patients will receive the modified Atkins diet in combination with a KetoCal tetrapak daily for the first month. The second month, no tetrapaks will be given.
干预措施: KetoCal (Dietary Supplement)
Modified Atkins diet
Patients will receive the modified Atkins diet for the first month. The second month, they will be given the choice to also use KetoCal in addition to the modified Atkins diet if they choose to do so.
干预措施: Modified Atkins diet (Dietary Supplement)
结局指标
主要结局
Ketosis
时间窗: 1 month
Time to urinary ketosis in days will be recorded and whether or not patients achieve serum ketosis at 1 month and 2 months.
次要结局
- Seizure reduction(2 months)
- Study completion rate(2 months)
- Tolerability and taste(2 months)
- Side effects(2 months)