ADHD and Nutrition: The Influence of Omega-3 on ADHD Related Symptoms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ADHD
- Sponsor
- University Hospital of North Norway
- Enrollment
- 332
- Locations
- 2
- Primary Endpoint
- Swanson, Nolan, and Pelham IV Questionnaire
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
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.
Detailed Description
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that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ADHD according to DSM-IV criteria
Exclusion Criteria
- •IQ below 70
- •infantil autism, psychosis, bipolar disorders and serious somatic disease
- •any abnormal or pathological blood test during trial
- •ADHD medication
Outcomes
Primary Outcomes
Swanson, Nolan, and Pelham IV Questionnaire
Time Frame: 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.
Secondary Outcomes
- 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)