EUCTR2005-005330-12-GB进行中（未招募）1 期
Omega-3 Fatty Acids Supplementation for Adolescent Boys with Attention Deficit Hyperactivity Disorder : a double-blind, randomized controlled trial - MAAFA
King's College London (IOP)0 个研究点目标入组 60 人开始时间: 2006年4月10日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Male adolescents aged 12-17 with
- •1)Both Conners’ Parents ADHD Rating Global Score and Conners' Teachers Rating Global Score are above 65
- •2)Meet ADHD criteria using a semi-structured interview (CHIPS; Weller, 2000) based on DSM-IV criteria.
- •All subjects will score higher than 70 on the prorated IQ as measured by The Kaufman Brief Intelligence Test (K-BIT) (Chin, 2001).
- •Only right handed males will be tested EEG
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 whose IQ is less than 70
- •4) Subjects who are not living in a family home or residential school
- •5) Subjects who are not in school during the intervention
- •6) Subjects who are non-English speakers
- •7) Serious or chronic disease
- •8) Low blood coagulation function (e.g. haemophilia, hepatic dysfunction, low-vitamin K)
- •9) Under these Medication: 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, other nutritional supplements.
- •10) Known allergy for fish product derivatives, Vitamin E derivatives, gelatine, olive oil
- •11) Pancreatic insufficiency
- •12) abnormal blood data: Triglyceride
- •For the EEG studies only, subjects with left handed, neurological problems or substance abuse will be excluded.
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