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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02986672
• Other study ID #: ADHD_Kvernmo
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 3, 2017
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2023
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• ADD
• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Dietary Supplement:
• Calanus oil
Omega-3 oil in form of calanus oil

Other:
• Medical Paraffin
2ml per day

Locations

Country	Name	City	State
Norway	Finnmarkssykehuset SANKS BUP Karasjok	Karasjok	Finnmark
Norway	University Hospital of North Norway	Tromsø	Troms

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: PLoS One. 2013;8(9). doi:10.1371/annotation/26c6b13f-b83a-4a3f-978a-c09d8ccf1ae2. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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