Clinical Trials Logo

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.


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that adolescents consuming more fish had lower levels of hyperactivity compared to those with lower fish consumption (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).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


Study Design


Related Conditions & MeSH terms

  • ADD
  • ADHD
  • Attention Deficit Disorder with Hyperactivity

NCT number NCT02986672
Study type Interventional
Source University Hospital of North Norway
Contact
Status Active, not recruiting
Phase N/A
Start date November 3, 2017
Completion date July 31, 2025

See also
  Status Clinical Trial Phase
Completed NCT03148782 - Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase N/A
Recruiting NCT06038942 - Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress N/A
Not yet recruiting NCT06456372 - Digital Health Intervention for Children With ADHD N/A
Completed NCT05518435 - Managing Young People With ADHD in Primary Care Study
Active, not recruiting NCT04978792 - Does Cultivating Self-compassion Improve Resilience to Criticism and Improve Mental Health in Adults With ADHD? N/A
Completed NCT03216512 - Effects of Noise Cancelling Headphones on Neurocognitive and Academic Outcomes in ADHD N/A
Not yet recruiting NCT02906501 - Effect of Risperidone on Cognitive Functions in Adolescents With ADHD and Behavioral Disturbances N/A
Completed NCT02829528 - Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention N/A
Completed NCT02900144 - Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) N/A
Terminated NCT02271880 - Improving Medication Adherence in ADHD Adolescents N/A
Completed NCT02562469 - ACTIVATE: A Computerized Training Program for Children With ADHD N/A
Recruiting NCT02255565 - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study Phase 4
Completed NCT02463396 - Mindfulness Training in Adults With ADHD N/A
Completed NCT01673594 - Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist Phase 4
Terminated NCT01733680 - Amiloride Hydrochloride as an Effective Treatment for ADHD Early Phase 1
Completed NCT02300597 - Internet-based Support for Young People With ADHD and Autism - a Controlled Study N/A
Active, not recruiting NCT01137318 - Combined Cognitive Remediation and Behavioral Intervention for Treatment of Attention-deficit/Hyperactivity Disorder (ADHD) Phase 2
Completed NCT01404273 - Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder N/A
Completed NCT00586157 - Study of Medication Patch to Treat Children Ages 6-12 With ADHD Phase 4
Completed NCT00573859 - The Reinforcing Mechanisms of Smoking in Adult ADHD Phase 1/Phase 2