ADHD and Nutrition: The Influence of Omega-3 on ADHD Related Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 332
- 试验地点
- 4
- 主要终点
- Swanson, Nolan, and Pelham IV Questionnaire
研究概览
简要总结
This study aims to determine if marine monounsaturated and polyunsaturated fatty acids can benefit children aged 6-16 years with ADHD and related symptoms. It is a randomized, double-blind, placebo-controlled study involving approximately 330 children from Norway. The study will assess ADHD symptoms reported by caregivers, teachers, and the child at baseline, after 6 months of treatment, and 6 months post-treatment. Secondary outcomes will include reading and writing difficulties, cognitive functions, and physical health.
详细描述
Children with ADHD often exhibit low blood levels of omega-3 fatty acids, which are not correlated with their diet. Low omega-3 levels are associated with poor cognition and behavior. Previous research indicates that omega-3 supplements can enhance literacy, behavior, memory, and reaction time in children with ADHD, although the improvements are generally small to modest.
A study on adolescent mental health in North Norway from 2003-2005 revealed that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).
Key limitations in existing studies include small sample sizes, varying methodologies, short intervention periods, and the absence of control groups. This study addresses these limitations by using whole marine oil from the zooplankton Calanus finmarchicus, which naturally contains stearidonic acid (a precursor to EPA) and astaxanthin, a natural antioxidant.
Previous clinical studies did not utilize pure oil from zooplankton such as Calanus finmarchicus. This oil is not chemically processed, retaining its natural antioxidants.
Blood tests will be conducted before and after the 6-month intervention period to measure the omega-3 index and include general hematology and biochemistry.
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
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- ADHD according to DSM-IV criteria
排除标准
- •IQ below 70
- •infantil autism, psychosis, bipolar disorders and serious somatic disease
- •any abnormal or pathological blood test during trial
- •ADHD medication
结局指标
主要结局
Swanson, Nolan, and Pelham IV Questionnaire
时间窗: 0, 3, 6, and 12 months
Description: The SNAP-IV is a 90-item scale used to evaluate symptoms of ADHD and related disorders. Score Range: Minimum value: 0, Maximum value: 270 Interpretation: Higher scores indicate worse symptoms.
次要结局
- Affective Reactivity Index(0, 3, 6, and 12 months)
- Strengths and Difficulties Questionnaire(0, 3, 6, and 12 months)
- Test of Variables of Attention(0, 3, 6, and 12 months)
- KIDSCREEN-52(0, 3, 6, and 12 months)
- Behavior Rating Inventory of Executive Function(0, 3, 6, and 12 months)
- ADHD Rating Scale by Russell Barkley(0, 3, 6, and 12 months)