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ADHDNCT02986672

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

A study testing Calanus oil and Medical Paraffin in people with ADHD and ADD, run by University Hospital of North Norway at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 16 years
Conditions the study is for
ADHD, ADD
What is being tested?
Calanus oil and Medical Paraffin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
332 participants
Where
2 sitesNorway
Study dates
3 Nov 2017to 20 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • ADHD according to DSM-IV criteria

Who cannot join

  • IQ below 70
  • infantil autism, psychosis, bipolar disorders and serious somatic disease
  • any abnormal or pathological blood test during trial
  • ADHD medication

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Finnmarkssykehuset SANKS BUP Karasjok

    Karasjok, Finnmark Fylke, 9730

  • University Hospital of North Norway

    Tromsø, Troms, 9038

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Conditions
ADHD, ADD
Being tested
Calanus oil, Medical Paraffin
Keywords
ADHD, omega 3, children, nutrition, MUFA, ADD, PUFA, Calanus, learning difficulties
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calanus oilDietary supplement

    Omega-3 oil in form of calanus oil

  • Medical ParaffinOther

    2ml per day

Study groups in NCT02986672
Study groupRoleWhat they receive
Calanus oilActive comparatorChildren receiving omega-3 in form om calanus oil in capsule form
Receives: Dietary Supplement: Calanus oil
PlaceboPlacebo comparatorChildren receiving medical paraffin in capsule form (2 ml volume per day)
Receives: Other: Medical Paraffin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0, 3, 6, and 12 months

Secondary outcomes (6)

  1. 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.

    Measured: 0, 3, 6, and 12 months

  2. ADHD Rating Scale by Russell Barkley

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

    Measured: 0, 3, 6, and 12 months

  3. 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.

    Measured: 0, 3, 6, and 12 months

  4. 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.

    Measured: 0, 3, 6, and 12 months

  5. 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.

    Measured: 0, 3, 6, and 12 months

  6. 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.

    Measured: 0, 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2016 (estimated)
  2. Study start3 Nov 2017
  3. Primary completion31 Jul 2024
  4. Study completion20 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02986672
Sponsor's protocol ID
ADHD_Kvernmo
Status last verified
Jun 2025
First submitted
8 Jan 2016
Last updated
22 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Raine A, Portnoy J, Liu J, Mahoomed T, Hibbeln JR. Reduction in behavior problems with omega-3 supplementation in children aged 8-16 years: a randomized, double-blind, placebo-controlled, stratified, parallel-group trial. J Child Psychol Psychiatry. 2015 May;56(5):509-20. doi: 10.1111/jcpp.12314. Epub 2014 Aug 22.

    PubMed 25146492

  • Gow RV, Hibbeln JR, Parletta N. Current evidence and future directions for research with omega-3 fatty acids and attention deficit hyperactivity disorder. Curr Opin Clin Nutr Metab Care. 2015 Mar;18(2):133-8. doi: 10.1097/MCO.0000000000000140.

    PubMed 25581035

  • Heilskov Rytter MJ, Andersen LB, Houmann T, Bilenberg N, Hvolby A, Molgaard C, Michaelsen KF, Lauritzen L. Diet in the treatment of ADHD in children - a systematic review of the literature. Nord J Psychiatry. 2015 Jan;69(1):1-18. doi: 10.3109/08039488.2014.921933. Epub 2014 Jun 16.

    PubMed 24934907

  • Milte CM, Sinn N, Buckley JD, Coates AM, Young RM, Howe PR. Polyunsaturated fatty acids, cognition and literacy in children with ADHD with and without learning difficulties. J Child Health Care. 2011 Dec;15(4):299-311. doi: 10.1177/1367493511403953. Epub 2011 Aug 9.

    PubMed 21828168

  • Stonehouse W, Conlon CA, Podd J, Hill SR, Minihane AM, Haskell C, Kennedy D. DHA supplementation improved both memory and reaction time in healthy young adults: a randomized controlled trial. Am J Clin Nutr. 2013 May;97(5):1134-43. doi: 10.3945/ajcn.112.053371. Epub 2013 Mar 20.

    PubMed 23515006

  • Richardson AJ. Omega-3 fatty acids in ADHD and related neurodevelopmental disorders. Int Rev Psychiatry. 2006 Apr;18(2):155-72. doi: 10.1080/09540260600583031.

    PubMed 16777670

  • Montgomery P, Burton JR, Sewell RP, Spreckelsen TF, Richardson AJ. Low blood long chain omega-3 fatty acids in UK children are associated with poor cognitive performance and behavior: a cross-sectional analysis from the DOLAB study. PLoS One. 2013 Jun 24;8(6):e66697. doi: 10.1371/journal.pone.0066697. Print 2013.

    PubMed 23826114

  • Hoper AC, Salma W, Sollie SJ, Hafstad AD, Lund J, Khalid AM, Raa J, Aasum E, Larsen TS. Wax esters from the marine copepod Calanus finmarchicus reduce diet-induced obesity and obesity-related metabolic disorders in mice. J Nutr. 2014 Feb;144(2):164-9. doi: 10.3945/jn.113.182501. Epub 2013 Nov 27.

    PubMed 24285691

  • Eilertsen KE, Maehre HK, Jensen IJ, Devold H, Olsen JO, Lie RK, Brox J, Berg V, Elvevoll EO, Osterud B. A wax ester and astaxanthin-rich extract from the marine copepod Calanus finmarchicus attenuates atherogenesis in female apolipoprotein E-deficient mice. J Nutr. 2012 Mar;142(3):508-12. doi: 10.3945/jn.111.145698. Epub 2012 Feb 8.

    PubMed 22323762

  • Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.

    PubMed 37058600

Questions about this trial

What is this clinical trial studying?

A study testing Calanus oil and Medical Paraffin in people with ADHD and ADD, run by University Hospital of North Norway at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Swanson, Nolan, and Pelham IV Questionnaire (time frame: 0, 3, 6, and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02986672, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.

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