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

June 17, 2025 updated by: University Hospital of North Norway

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).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

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Finnmark
      • Karasjok, Finnmark, Norway, 9730
        • Finnmarkssykehuset SANKS BUP Karasjok
    • Troms
      • Tromsø, Troms, Norway, 9038
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 3, 6, and 12 months
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
0, 3, 6, and 12 months
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.
0, 3, 6, and 12 months
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.
0, 3, 6, and 12 months
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.
0, 3, 6, and 12 months
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.
0, 3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Investigators

  • Study Director: Siv Kvernmo, MD PhD, University of Tromso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2017

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

September 20, 2024

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimated)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

June 22, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADHD_Kvernmo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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