Intervention With Omega-3 in Children With Attention Deficit Hyperactivity Disorder(ADHD)

Study Overview
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Brief Summary
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This study aim to evaluate the effect of marine monounsaturated and polyunsaturated fatty acids on children aged from 6-16 years, with ADHD/ADD and related symptoms. The study is a randomized, double-blind placebo-control study including approximately 330 children from Norway. The primary outcome measure is ADHD core symptoms reported by caregivers, teachers and the child at 0 months (baseline), 6 months (end of treatment) and 12 months (6 months post treatment). The secondary outcome measures are reading and writing disabilities, cognitive functions, and physical Health.

Detailed Description
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Children with ADHD are shown to have low blood levels of omega-3 fatty acids, not related to diet. Low levels of omega-3 has also been directly related to poor cognition and behavior. Trials have shown that supplement with omega-3 may improve literacy and behavior in children with ADHD symptoms. It has also been shown to improve both memory and reaction time. The effect sizes found in meta analysis of placebo- controlled clinical trials on ADHD core symptoms are small to modest. In a study of adolescent mental health in North Norway in 2003-2005 a significant association was found between intake of fish and hyperactivity as adolescents with a high intake showed less hyperactivity than peers with a low intake (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo). There are several key limitations to the existing studies. Underpowered sample size, different methodology and short intervention periods are some factors raising the question of effect size. Other trials have no control group. We are designing this study taking these limitations into consideration. In addition we are using whole marine oil from the zooplankton Calanus finmarchicus that has a high natural content of stearidonic acid 18:3 n-3 that is a precursor to EPA. The oil also has a high content of astaxanthines - a natural antioxidant. Earlier clinical studies have not used pure oil from zooplankton such as Calanus finmarchicus. The oil is not processed chemically such as ethylation, that not only alter the structure of the oil, but also devoid the product of its natural antioxidants. Blood tests are taken before and after a 6 month intervention period. These blood tests entail both omega-3 index analysis as well as general hematology and biochemistry.

Official Title
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ADHD and Nutrition: The Influence of Omega-3 on ADHD Related Symptoms

Conditions
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ADHD, ADD

Intervention / Treatment
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* Dietary Supplement: Calanus oil
* Other: Medical Paraffin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - ADHD or ADD 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 Omega-3 supplement taken until 3 months before inclusion

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calanus oil<br>Children receiving omega-3 in form om calanus oil in capsule form | Dietary Supplement: Calanus oil<br>* Omega-3 oil in form of calanus oil<br>|
| Placebo Comparator: Placebo<br>Children receiving medical paraffin in capsule form (2 ml volume per day) | Other: Medical Paraffin<br>* 2ml per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD rating scale by Russel Barkley | Reduction in symptom score | 0, 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BRIEF - Behavior Rating Inventory of Executive Function | Reduction in symptom score | 0, 3, 6, and 12 months | 
| SNAP-IV The Swanson Nolan and Pelham-IV Questionnaire | Change | 0, 3, 6, and 12 months | 
| ARI - Affective Reactivity Index - a scale that contains six symptom items and one impairment item about irritability | Reduction in symptoms | 0, 3, 6, and 12 months | 
| TOVA CPT - Continuous Performance test - a task-oriented computerized assessment of attention-related problems in individuals aged 8 years and older | Change | 0, 3, 6, and 12 months | 
| SDQ - Strength and Difficulty Questionnaire | Psychological screening tool used to assess the behavioral and emotional strengths and difficulties of children and adolescents, consisting of 25 items across five dimensions | 0, 3, 6, and 12 months | 
| Kid-Screen-52 | 52 items examining Health-related Quality of Life | 0, 3, 6, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, omega 3, children, nutrition, MUFA, ADD, PUFA, Calanus, learning difficulties