Skip to main content
OpenTrials
Completed

NCT Number: NCT02986672

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ADHD ADD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Finnmarkssykehuset SANKS BUP Karasjok, Karasjok, Finnmark Fylke, Norway

Loading trial locations.

About this study

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that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calanus oil

Dietary Supplement

Omega-3 oil in form of calanus oil

Medical Paraffin

Other

2ml per day

Primary outcomes

  1. 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

  1. Behavior Rating Inventory of Executive Function

    Time frame: 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.

  2. ADHD Rating Scale by Russell Barkley

    Time frame: 0, 3, 6, and 12 months

    Reduction in symptom score. Reduction in symptom score. Minimum value: 0, Maximum value: 54. Higher scores

  3. Affective Reactivity Index

    Time frame: 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.

  4. Test of Variables of Attention

    Time frame: 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.

  5. Strengths and Difficulties Questionnaire

    Time frame: 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.

  6. KIDSCREEN-52

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2016
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.