ADD, ADHD
Conditions
Keywords
ADHD, omega 3, children, nutrition, MUFA, ADD, PUFA, Calanus, learning difficulties
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that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).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.
Interventions
DIETARY_SUPPLEMENTCalanus oil
Omega-3 oil in form of calanus oil
OTHERMedical Paraffin
2ml per day
Sponsors
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Swanson, Nolan, and Pelham IV Questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| ADHD Rating Scale by Russell Barkley | 0, 3, 6, and 12 months | Reduction in symptom score. Reduction in symptom score. Minimum value: 0, Maximum value: 54. Higher scores |
| Affective Reactivity Index | 0, 3, 6, and 12 months | 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. |
| Behavior Rating Inventory of Executive Function | 0, 3, 6, and 12 months | 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. |
| Strengths and Difficulties Questionnaire | 0, 3, 6, and 12 months | 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. |
| KIDSCREEN-52 | 0, 3, 6, and 12 months | 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. |
| Test of Variables of Attention | 0, 3, 6, and 12 months | 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. |
Countries
Norway
Outcome results
None listed