NCT00770627Unknown4 期
A Randomized , Controlled, Doulbe Blind Placebo Trial To Evaluate The Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- ADHD rating scale
研究概览
简要总结
Principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the ADHD children's behaviour during 12 weeks on two years. The secondary focus is to evaluate the effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities, anxiety and depression.
The omega 3 fatty acids don't present adverse side effects. The inclusion to the trial could avoid the intake the methylphenidate and its associated adverse side effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6 to 15 years and 11 months of age ADHD children with hyperactivity confirmed dy DSM IV criteria Children and parents' consent
排除标准
- •Without methylphenidate treatment Fish or other sea products allergic Intake of sea omega 3 fatty acids supplments more one week during 3 months before the trial Children need quickly to take methylphenidate: social, family, or school risk Intake methylphenidate 30 days before the trial or/and intake it during one consecutive week
结局指标
主要结局
ADHD rating scale
时间窗: 5 minutes
次要结局
- Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity)(3 hours)
研究者
研究点 (4)
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