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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2025
  • participants needed
    330
  • sponsor
    University Hospital of North Norway
Updated on 30 May 2022
fatty acids
attention deficit hyperactivity disorder
attention deficit disorder

Summary

This study aim to evaluate the effect of marine monounsaturated and polyunsaturated fatty acids on children aged from 6-13 years, with ADHD/ADD and related symptoms. The study is a randomized, double-blind placebo-control study including approximately 330 children from Norway. The primary outcome measure is ADHD core symptoms reported by caregivers, teachers and the child at 0 months (baseline), 6 months (end of treatment) and 12 months (6 months post treatment). The secondary outcome measures are reading and writing disabilities, cognitive functions, and physical Health.

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 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of fish and hyperactivity as adolescents with a high intake showed less hyperactivity than peers with a low intake (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).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.

Details
Condition ADHD, ADD
Treatment Calanus oil, Medical Paraffin
Clinical Study IdentifierNCT02986672
SponsorUniversity Hospital of North Norway
Last Modified on30 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

ADHD or ADD 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
Omega-3 supplement taken until 3 months before inclusion
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note