NCT00294593已完成2 期
One-year Double-blind Placebo-controlled Phase 2-3 Study to Evaluate the Effect of Oral Folinic Acid Treatment (1mg/kg/d) on the Psychomotor Development of Young Down Syndrome Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Score on a psychomotor development scale after a 6 and 12 months treatment
研究概览
简要总结
The purpose of this study is to determine whether folinic acid can improve developmental quotient of young Down syndrome patients, given that these present signs of folate deficiency which are known to cause reversible neurological, psychiatric and cognitive disorders.
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
- Double
入排标准
- 年龄范围
- 3 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Down syndrome without mosaicism
- •age 3 to 30 months
- •weight over 4 kg
- •possible assessment by the revised Brunet-Lezine scale
排除标准
- •history of leukemia
- •West syndrome or non-stable epilepsy
- •non-stable thyroxin treatment
结局指标
主要结局
Score on a psychomotor development scale after a 6 and 12 months treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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