Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • ADD
  • ADHD
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 6 years and 13 years
Gender
Both males and females

Description

Children with ADHD are shown to have low blood levels of omega-3 fatty acids, not related to diet. Low levels of omega-3 has also been directly related to poor cognition and behavior. Trials have shown that supplement with omega-3 may improve literacy and behavior in children with ADHD symptoms. It ...

Children with ADHD are shown to have low blood levels of omega-3 fatty acids, not related to diet. Low levels of omega-3 has also been directly related to poor cognition and behavior. Trials have shown that supplement with omega-3 may improve literacy and behavior in children with ADHD symptoms. It has also been shown to improve both memory and reaction time. The effect sizes found in meta analysis of placebo- controlled clinical trials on ADHD core symptoms are small to modest. In a study of adolescent mental health in North Norway in 2003-2005 a significant association was found between intake of fish and hyperactivity as adolescents with a high intake showed less hyperactivity than peers with a low intake (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo). There are several key limitations to the existing studies. Underpowered sample size, different methodology and short intervention periods are some factors raising the question of effect size. Other trials have no control group. We are designing this study taking these limitations into consideration. In addition we are using whole marine oil from the zooplankton Calanus finmarchicus that has a high natural content of stearidonic acid 18:3 n-3 that is a precursor to EPA. The oil also has a high content of astaxanthines - a natural antioxidant. Earlier clinical studies have not used pure oil from zooplankton such as Calanus finmarchicus. The oil is not processed chemically such as ethylation, that not only alter the structure of the oil, but also devoid the product of its natural antioxidants.

Tracking Information

NCT #
NCT02986672
Collaborators
Not Provided
Investigators
Study Director: Siv Kvernmo, MD PhD University of Tromso