NCT03536845已完成3 期
Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy: a Randomized Controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Vitamin D level < 75 nmol/L
研究概览
简要总结
To determine the maintenance dose of vitamin D supplementation required for children with epilepsy to maintain normal vitamin D level.
详细描述
children aged 2-16 years diagnosed with idiopathic epilepsy will be randomized to receive either cholecalciferol doses (400IU vs 1000IU) with follow up at 3 and 6 months post supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 2-16 years who were diagnosed with Epilepsy and being treated with AEDs
- •Followed up in the outpatient pediatric neurology clinic at King Khalid University Hospital during the period of two years.
排除标准
- •Children with pre-existing vitamin D metabolism problems; because they are known to need different vitamin D doses and monitoring for clinical improvement:
- •Vitamin D dependent rickets
- •Malabsorption syndromes like celiac disease, inflammatory bowel disease
- •Renal disease
- •Hepatic disease
- •Children who are not safe to start vitamin D supplementation; because vitamin D supplementation will causes toxicity and induces nephrocalcinosis:
- •Hypercalcemia at baseline total corrected calcium >2.5mg/dl
- •Vitamin D level > 250 nmol/L
- •Urine calcium: creatinine ration > 1.2 mol/mol, or > 0.41g/g.
研究组 & 干预措施
400 IU
Active Comparator
干预措施: Vitamin D 3 (Drug)
1000 IU
Active Comparator
干预措施: Vitamin D 3 (Drug)
结局指标
主要结局
Vitamin D level < 75 nmol/L
时间窗: 6 months of supplementation
次要结局
- Seizure rate(6 months of supplementation)
- bone mineral density (BMD) measurement(6 months of supplementation)
- Cost- effectiveness of vitamin D supplementation(6 months of supplementation)
- Safety: Prevalence of hypercalcemia total calcium >2.7mg/dl, 25 OH vit D level> 250 nmol/l, and Urine calcium: creatinine ration > 1.2 mol/mol, or > 0.41g/g.(6 months of supplementation)
研究者
Reem Al Khalifah
Assistant Professor
King Saud University
研究点 (1)
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