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

NCT02986672 | Completed

• 1 other identifier: ADHD_Kvernmo
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 2

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.

Conditions

ADHD; ADD

Keywords

ADHD; omega 3; children; nutrition; MUFA; ADD; PUFA; Calanus; learning difficulties

Outcome Measures

Primary Outcomes (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.

  0, 3, 6, and 12 months

Secondary Outcomes (6)

• Behavior Rating Inventory of Executive Function

  0, 3, 6, and 12 months

• ADHD Rating Scale by Russell Barkley

  0, 3, 6, and 12 months

• Affective Reactivity Index

  0, 3, 6, and 12 months

• Test of Variables of Attention

  0, 3, 6, and 12 months

• Strengths and Difficulties Questionnaire

  0, 3, 6, and 12 months

Study Arms (2)

Calanus oil

ACTIVE COMPARATOR

Children receiving omega-3 in form om calanus oil in capsule form

Dietary Supplement: Calanus oil

Placebo

PLACEBO COMPARATOR

Children receiving medical paraffin in capsule form (2 ml volume per day)

Other: Medical Paraffin

Interventions

Calanus oil DIETARY_SUPPLEMENT

Omega-3 oil in form of calanus oil

Calanus oil

Medical Paraffin OTHER

2ml per day

Placebo

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- ADHD according to DSM-IV criteria

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (2)

Finnmarkssykehuset SANKS BUP Karasjok

Karasjok, Finnmark Fylke, 9730, Norway

Location

University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

Related Publications (10)

• 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.

  PMID: 25146492 BACKGROUND

• 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.

  PMID: 25581035 BACKGROUND

• 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.

  PMID: 24934907 BACKGROUND

• 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.

  PMID: 21828168 BACKGROUND

• 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.

  PMID: 23515006 BACKGROUND

• 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.

  PMID: 16777670 BACKGROUND

• 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.

  PMID: 23826114 BACKGROUND

• 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.

  PMID: 24285691 BACKGROUND

• 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.

  PMID: 22323762 BACKGROUND

• 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.

  PMID: 37058600 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Siv Kvernmo, MD PhD

  University of Tromso

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: December 8, 2016
• Study Start: November 3, 2017
• Primary Completion: July 31, 2024
• Study Completion: September 20, 2024
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)