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.
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that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
Omega-3 oil in form of calanus oil
2ml per day
Finnmarkssykehuset SANKS BUP Karasjok
Karasjok, Finnmark Fylke, Norway
University Hospital of North Norway
Tromsø, Troms, Norway
Swanson, Nolan, and Pelham IV Questionnaire
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.
Time frame: 0, 3, 6, and 12 months
Behavior Rating Inventory of Executive Function
Description: The BRIEF assesses executive function behaviors in children and adolescents in home and school environments. Score Range: Minimum value: 0, Maximum value: 240 Interpretation: Higher scores indicate worse executive function behaviors.
Time frame: 0, 3, 6, and 12 months
ADHD Rating Scale by Russell Barkley
Reduction in symptom score. Reduction in symptom score. Minimum value: 0, Maximum value: 54. Higher scores
Time frame: 0, 3, 6, and 12 months
Affective Reactivity Index
Description: The ARI is a scale that measures irritability, consisting of six symptom items and one impairment item. Score Range: Minimum value: 0, Maximum value: 12 Interpretation: Higher scores indicate greater irritability.
Time frame: 0, 3, 6, and 12 months
Test of Variables of Attention
Description: The TOVA is a computerized test that measures attention-related problems in individuals aged 8 years and older. Score Range: Minimum value: -10, Maximum value: 10 Interpretation: Higher scores indicate better attention performance.
Time frame: 0, 3, 6, and 12 months
Strengths and Difficulties Questionnaire
Description: The SDQ is a psychological screening tool used to assess the behavioral and emotional strengths and difficulties of children and adolescents, consisting of 25 items across five dimensions. Score Range: Minimum value: 0, Maximum value: 50 Interpretation: Higher scores indicate more behavioral and emotional difficulties.
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332
Time frame: 0, 3, 6, and 12 months
KIDSCREEN-52
Description: The KIDSCREEN-52 is a questionnaire that examines Health-Related Quality of Life (HRQoL) in children and adolescents, consisting of 52 items. Score Range: Minimum value: 52, Maximum value: 260 Interpretation: Higher scores indicate better health-related quality of life.
Time frame: 0, 3, 6, and 12 months