ACTRN12610000978066招募中未知
The effects of a naturally occurring combination of omega-3s on children and adolescents with hyperactivity and inattention
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- Pharmalink
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 6 Years 至 14 Years（—）
- 性别
- All
入选标准
- •1. Healthy non-smoking males and females aged between 7 and 13 years.
- •2. DSM-IV ADHD rating score above 15
- •3. Fluent in English
- •4. Parent/legal guardian provide a personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial.
- •5. Participant provide a signed copy of a simplified children’s consent form
排除标准
- •1. Medical diagnosis other than ADHD, Oppositional defiance disorder or similar behavioural disorder
- •2. Currently taking any medication (other than stimulants if a formal diagnosis of ADHD or other behavioural disorder is present)
- •3. History of / current heart disease or high blood pressure or diabetes
- •4. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers)
- •5. Pregnant or breast feeding
- •6. Unable to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
- •7. Allergy to shellfish
- •8. Epilepsy or photosensitive
研究者
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