NCT02986672

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: University Hospital of North Norway · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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.

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that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Calanus oil	Omega-3 oil in form of calanus oil
OTHER	Medical Paraffin	2ml per day

Timeline

• Start date: 2017-11-03
• Primary completion: 2024-07-31
• Completion: 2024-09-20
• First posted: 2016-12-08
• Last updated: 2025-06-22

Locations

2 sites across 1 country: Norway