NCT00700323Unknown2 期
Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 1
研究概览
简要总结
To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.
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
- 8 Years 至 13 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental written informed consent.
- •Age: 13≥ years ≥8 (including).
- •Gender: both male and female.
- •TOVA computerized test score ≤-1.8 at baseline.
- •Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew.
- •Normal weight and height according to Israeli standards.
- •21 days without any treatment for ADHD symptoms, whether medication or food supplement.
排除标准
- •History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
- •Pervasive developmental disorder or Non-Verbal Learning Disability
- •Any evidence of psychotic disorders, suicidal risk, any current psychiatric co-morbidity that required psychiatric pharmacotherapy.
- •History of allergic reactions or sensitivity to marine products (seafood), soy or corn as well as any illness, which may jeopardize the participants health or limit their successful trial completion.
- •Having a sibling already included in the study.
研究者
研究点 (1)
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