Magnesium Supplementation for Children With Drug Resistant Idiopathic Epilepsy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- IQ improvement
研究概览
简要总结
Effect of oral magnesium sulfate (Mg) supplementation will be studied. Children with drug resistant idiopathic epilepsy following up in Pediatric Neurology Clinic, Ain Shams University, will be randomized to either Mg add-on treatment group or anti-epileptic drugs AEDs alone. Serum magnesium, seizure control and Intelligent quotation (IQ) will be done at base line and after 6 months of treatment.
详细描述
The Aim of this work was to study the effect of Magnesium as add on therapy on clinical seizure control in drug resistant idiopathic epilepsy and IQ.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with drug resistant idiopathic epilepsy
排除标准
- •Structural, Metabolic, Infectious and Unknown etiology epilepsy
- •Any neurological disease other than epilepsy
- •Any nutritional disorder
- •Any other systemic diseases (including Renal disease, Cardiac arrhythmia)
- •Drug intake other than antiepileptic drugs (AED)
研究组 & 干预措施
Magnesium add-on
20 children with drug resistant epilepsy will receive oral magnesium sulfate 6 ml per day which equivalent to 400 mg elemental magnesium (Yuen & Sander, 2012) for 6 months and their regular antiepileptic drugs.
干预措施: Magnesium (Dietary Supplement)
Antiepileptic drugs only
20 children with drug resistant epilepsy will receive their regular antiepileptic drugs and placebo for 6 months.
干预措施: Placebo - Concentrate (Drug)
结局指标
主要结局
IQ improvement
时间窗: 6-months
Change from base line IQ (Wechsler Intelligence Scale-Revised for Children and Adults)
Seizure control
时间窗: 6 months
Change from base line seizure frequency, severity (Chalfont scale) at 6 months.
次要结局
未报告次要终点
研究者
Sahar M.A. Hassanein, MD
Professor of Pediatrics and Head of Pediatric Neurology Unit, Children's
Ain Shams University