Phase 2/3 Study of the Modified Atkins Diet in Young Children With Refractory Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Proportion of children with > 50% seizure reduction at 3 months
研究概览
简要总结
The modified Atkins diet is a non-pharmacologic therapy for intractable childhood epilepsy that was designed to be a less restrictive alternative to the traditional ketogenic diet. This diet is started on an outpatient basis without a fast, allows unlimited protein and fat, and does not restrict calories or fluids. Modified Atkins diet is of special importance in resource constraint settings with paucity of trained dieticians. However, there is paucity published data on the use of the modified Atkins diet in refractory epilepsy in young children. This study aims to evaluate the efficacy and tolerability of the modified Atkins diet in refractory epilepsy in young children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 9 months to 3 years.
- •Seizures persisting at least three per week for > 1 month despite the appropriate use of at least 2 Anti-epileptic drugs.
排除标准
- •Known or suspected inborn error of metabolism, as evidenced by: Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination And/ or 2 or more of the following biochemical abnormalities High blood ammonia (>80mmol/L), High arterial lactate (>2 mmol/L), metabolic acidosis (pH <7.2), hypoglycaemia (blood sugar <40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
- •Motivational or psychosocial issues in the family which would preclude compliance
- •Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
- •Severe acute malnutrition.
研究组 & 干预措施
Children on Modified Atkin Diet
干预措施: Modified Atkin Diet (Other)
结局指标
主要结局
Proportion of children with > 50% seizure reduction at 3 months
时间窗: After 3 months of diet initiation
次要结局
- Frequency of adverse effects of the modified Atkins diet.(3 months)
研究者
Satinder Aneja
Director Professor
Lady Hardinge Medical College