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临床试验/NCT00700323
NCT00700323Unknown2 期

Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2008年7月最近更新:
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

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

申办方类型
Other Gov

研究点 (1)

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