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

July 31, 2023 updated by: University Hospital of North Norway

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

This study aim to evaluate the effect of marine monounsaturated and polyunsaturated fatty acids on children aged from 6-16 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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of fish and hyperactivity as adolescents with a high intake showed less hyperactivity than peers with a low intake (unpublished results from The Norwegian Arctic Adolescent Health Study, Siv Kvernmo).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

Blood tests are taken before and after a 6 month intervention period. These blood tests entail both omega-3 index analysis as well as general hematology and biochemistry.

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
    • Finnmark
    • Troms
      • Tromsø, Troms, Norway, 9038
        • Recruiting
        • University Hospital of North Norway
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Calanus oil
Children receiving omega-3 in form om calanus oil in capsule form
Dietary supplement: Calanus oil
Omega-3 oil in form of calanus oil
Placebo Comparator: Placebo
Children receiving medical paraffin in capsule form (2 ml volume per day)
Other: Medical Paraffin
2ml per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADHD rating scale by Russel Barkley
Time Frame: 0, 3, 6, and 12 months
Reduction in symptom score
0, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BRIEF - Behavior Rating Inventory of Executive Function
Time Frame: 0, 3, 6, and 12 months
Reduction in symptom score
0, 3, 6, and 12 months
SNAP-IV The Swanson Nolan and Pelham-IV Questionnaire
Time Frame: 0, 3, 6, and 12 months
Change
0, 3, 6, and 12 months
ARI - Affective Reactivity Index - a scale that contains six symptom items and one impairment item about irritability
Time Frame: 0, 3, 6, and 12 months
Reduction in symptoms
0, 3, 6, and 12 months
TOVA CPT - Continuous Performance test - a task-oriented computerized assessment of attention-related problems in individuals aged 8 years and older
Time Frame: 0, 3, 6, and 12 months
Change
0, 3, 6, and 12 months
SDQ - Strength and Difficulty Questionnaire
Time Frame: 0, 3, 6, and 12 months
Psychological screening tool used to assess the behavioral and emotional strengths and difficulties of children and adolescents, consisting of 25 items across five dimensions
0, 3, 6, and 12 months
Kid-Screen-52
Time Frame: 0, 3, 6, and 12 months
52 items examining Health-related Quality of Life
0, 3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Investigators

  • Study Director: Siv Kvernmo, MD PhD, University of Tromso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2017

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimated)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADHD_Kvernmo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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