The Effects of Eicosapentaenoic Acid (EPA)/ Docosahexaenoic Acid (DHA) Supplementation on Cognitive Control in Children With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Cognitive control task - functional MRI
研究概览
简要总结
Forty children with and 40 children without Attention deficit Hyperactivity Disorder (ADHD) receive Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) or placebo via a dietary intervention. Cognitive control functions are measured with functional Magnetic Resonance Imaging (MRI) before and after the intervention. Behavioural change is monitored with behavioural scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for subjects with ADHD
- •8-12 year old boys
- •Diagnostic and Statistical Manual 4th edition (DSM-IV (APA, 1994)) diagnosis of ADHD, according to Diagnostic Interview Schedule for Children (DISC)
- •Scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form(TRF)
- •Ability to speak and comprehend Dutch.
- •Used to daily consumption of margarine
- •Inclusion criteria for controls
- •8-12 year old boys
- •No DSM-IV (APA, 1994) diagnosis, according to DISC interview
- •No scores in the clinical range on the Child Behaviour Checklist (CBCL) and Teacher Rating Form (TRF)
- •Ability to speak and comprehend Dutch. 5 Used to daily consumption of margarine
排除标准
- •mental retardation (IQ < 70)
- •major illness of the cardiovascular, the endocrine, the pulmonary or the gastrointestinal system
- •presence of metal objects in or around the body (pacemaker, dental braces)
- •history of or present neurological disorder
- •regular use of n-3 or n-6 fatty acid dietary supplements, products fortified with EPA or DHA, a regular diet high in fatty fish (= 1 serving per week) or participation in intervention studies or (school-) health programs in the four months prior to study participation.
研究组 & 干预措施
ADHD active
4 month intervention with EPA/DHA in ADHD group
干预措施: Eicosapentaenoic acid / Docosahexaenoic acid (Dietary Supplement)
ADHD Placebo
4 month dietary intervention with placebo in ADHD group
干预措施: Placebo dietary intervention (MUFA) in ADHD group (Dietary Supplement)
Active Healthy control
4 month dietary intervention with DHA/EPA in healthy control group
干预措施: Eicosapentaenoic acid / Docosahexaenoic acid (Dietary Supplement)
Healthy placebo
4 month dietary intervention with placebo in healthy control group
干预措施: Placebo dietary intervention (MUFA) in healthy control group (Dietary Supplement)
结局指标
主要结局
Cognitive control task - functional MRI
时间窗: change over 16 week intervention period (pre/post)
次要结局
- Fatty acids status from cheek cells (swabs)(Change over 16 week intervention period (pre/post))
- Behavioural scales: - Child Behaviour Checklist (CBCL) / Teacher Report Form (TRF) - Strengths and Weaknesses of ADHD-symptoms and Normal behaviour (SWAN) questionnaire(Change over 16 week intervention period (pre/post))