Docosahexaenoic Acid Augmentation of Cortical Attention Networks in ADHD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV)
研究概览
简要总结
The study hypothesis is that DHA is more effective than placebo in increasing brain activation and reducing symptoms in psychostimulant-free children with ADHD.
详细描述
This study aims to determine the effects of 10-week dietary supplementation with the long-chain omega-3 fatty acid docosahexaenoic acid (DHA) or placebo on prefrontal cortical structural and functional connectivity using several neuroimaging techniques: DTI (Diffusion Tensor Imaging), 1H MRS(Proton Magnetic Resonance Spectroscopy), and fMRI (Functional Magnetic Resonance Imaging) in psychostimulant-free children with attention deficit hyperactivity disorder (ADHD). It is postulated that DHA supplements will increase brain activation and reduce ADHD symptomatology.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent/assent
- •Ages 5-15 years old
- •Meets DSM-IV-TR criteria for ADHD as determined by the KSADS
排除标准
- •Contraindication to an MRI scan (i.e., braces, claustrophobia)
- •A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy)
- •Greater than 1 year outside appropriate age/grade level
- •A history of intolerance or hypersensitivity to omega-3 fatty acids
- •Currently taking omega-3 supplements
- •Not proficient in English language
- •Any history of a hematological disorder or concomitant use of anticoagulant medications
- •Personal history of an Axis I psychiatric disorder other than ADHD
- •Inability to swallow capsules
研究组 & 干预措施
Placebo
Corn/soy oil placebo capsules that are similar in shape and color to the DHA capsules given over 10 weeks
干预措施: Placebo (Drug)
DHA Omega-3
Long-chain omega-3 fatty acid docosahexaenoic acid (DHA) at 1,200 mg/day, 600 mg twice daily for 10 weeks
干预措施: DHA Omega-3 (Drug)
结局指标
主要结局
Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV)
时间窗: 10 weeks
Attention-Deficit Hyperactivity Disorder Rating Scale Version IV (ADHD-RS-IV) Min score: 0 Max score: 54 Higher score = more severe ADHD symptoms
次要结局
未报告次要终点
研究者
Robert McNamara
Associate Professor
University of Cincinnati