ISRCTN27741572已完成不适用
Omega-3 fatty acids supplementation for adolescent boys with attention deficit hyperactivity disorder: a double-blind, randomized controlled trial
King's College London (UK)0 个研究点目标入组 60 人开始时间: 2006年5月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Male adolescents aged 12-17 years of age from special schools in London and Kent in the UK
- •2. Subjects who meet ADHD diagnosis criteria using a structured interview (CHIPS) based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
- •3. Subjects who have Conners? Parents ADHD Rating Global Scale and Conners? Teachers ADHD Rating Global Scale above 65
排除标准
- •1. Subjects who took omega-3 supplement within 6 months
- •2. A personal history of diabetes or other metabolic disorder influencing fatty acid metabolism
- •3. Subjects who are not living in a family home or residential school
- •4. Subjects who are under special diets (e.g. vegetarian, taking supplements)
- •5. Subjects who are not in school during the intervention
- •6. Serious or chronic disease
- •7. Low blood coagulation function (e.g. haemophilia, hepatic dysfunction, low-vitamin K)
- •8. Under these medications: alpha tocopherol, selected anticoagulants (aspirin, warfarin, heparin), cyclosporine, clopidogrel, etretinate and topical steroids, cholesterol-lowering medications (atorvastatin, lovastatin, and simvastatin), non-steroidal anti-inflammatory drugs (NSAIDs), dalteparin, dipyrdamole, enoxaparin, ticlopedine
- •9. Known allergy for fish product derivatives, Vitamin E derivatives, gelatine
- •10. Abnormal blood data in the baseline assessment
- •11. All subjects will score higher than 70 on the prorated IQ as measured by The Kaufman Brief Intelligence Test (K-BIT)
- •12. For the electroencephalogram (EEG) studies only, subjects with left handed, neurological problems or substance abuse will be excluded
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