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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.
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that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calanus oil | Active Comparator | Children receiving omega-3 in form om calanus oil in capsule form |
|
| Placebo | Placebo Comparator | Children receiving medical paraffin in capsule form (2 ml volume per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calanus oil | Dietary Supplement | Omega-3 oil in form of calanus oil |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 3, 6, and 12 months |
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Inclusion Criteria:
- ADHD according to DSM-IV criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siv Kvernmo, MD PhD | University of Tromso | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Finnmarkssykehuset SANKS BUP Karasjok | Karasjok | Finnmark Fylke | 9730 | Norway | ||
| University Hospital of North Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25146492 | Background | 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. | |
| 25581035 | Background |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Medical Paraffin |
| Other |
2ml per day |
|
| ADHD Rating Scale by Russell Barkley |
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 | 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 | 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 | 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 | 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 |
| Tromsø |
| Troms |
| 9038 |
| Norway |
| 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. |
| 24934907 | 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. |
| 21828168 | 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. |
| 23515006 | 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. |
| 16777670 | 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. |
| 23826114 | 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. |
| 24285691 | 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. |
| 22323762 | 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. |
| 37058600 | Derived | 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. |