Omega-3 Supplementation and Behavior Problems

Aggression Clinical Trial

Official title:

Omega-3 Supplementation and Behavior Problems in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334098
• Other study ID #: GRF-11402514
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2015
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: City University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of this project are as follows:

1. To assess whether omega-3 dietary supplementation for six months can reduce externalizing behavior problems (antisocial and aggressive behavior) in schoolchildren aged 8 to 18, both at the end of treatment and six months post-treatment

2. To assess whether omega-3 supplementation is more effective in children with more psychopathic-like traits.

Description:

Externalizing behavior problems (aggressive and antisocial behaviors) are widely recognized as predisposing to significant mental health problems and violence among adolescents in secondary schools. These in turn result in enormous economic and social costs to schools as well as to society. These costs include mental illness, crime, and violence. Similarly, violence is widely recognized as a major public health problem which has also largely defied successful intervention and prevention. Because an increasing body of research is documenting health and neurobiological risk factors for aggression and violence, part of this prevention failure may be due to intervention efforts ignoring biological contributory factors which include impaired neurocognitive and psychophysiological functioning. One benign biological intervention that may help attenuate behavior problems in children consists of omega-3 supplementation of the diet, a long-chain fatty acid critical for brain structure and function.

The overarching aim of this study is to assess whether omega-3 supplementation can reduce the base level of externalizing behavior problems in children and adolescents. A secondary but important aim is to assess whether any behavioral improvement may be greater in more psychopathic children. The specific aims are as follows:

1. To assess the effectiveness of omega-3 dietary supplementation in reducing externalizing behaviors in adolescents.

2. To assess whether omega-3 supplementation leads to greater improvement in children with psychopathic-like traits.

Hypotheses will be tested in a placebo-controlled, double-blind, randomized trial involving 8 to18 year-old adolescents drawn from primary and secondary schools in Hong Kong. Omega-3 supplementation will be in the form of a Norwegian fruit juice drink. 300 adolescents will be randomly assigned into: (1) omega-3 supplemented drink, (2) placebo drink, (3) treatment-as-usual controls. Behavioral measures will be assessed at baseline (0 months), end of treatment (6 months), and 6 months post-treatment (12 months).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• children and adolescents between the age 8 and 18

• participants who does not fit in any of the following exclusion criteria

Exclusion Criteria:

• unwilling to participate in a randomized, double-blind, placebo controlled trial,

• unable to give written, informed parental consent and assent from children,

• on medication that may modify lipid metabolism in the past 3 months

• significant use of omega-3 supplements in the past 6 months

• seafood allergies

• mental retardation

• epilepsy

Related Conditions & MeSH terms

• Aggression
• Antisocial Behavior
• Antisocial Personality
• Antisocial Personality Disorder
• Problem Behavior

Intervention

Dietary Supplement:
• Omega-3 supplemented drink
The drink has apple/ pear/ pomegranate taste which is well accepted by children and adolescents, is rich in natural antioxidants to help prevent oxidation of omega-3. The drink can be taken at any time during the day. 1/3 of the participants will be assigned to the omega-3 group after randomization. They are going to take the treatment for 6 months. They will be assessed at baseline, end of treatment and 6 months post-treatment.
• Smartfish
Treatment duration is 6 months. They will be assessed at baseline (0 months), end of treatment (6 months) and 6 months post-treatment (12 months).

Locations

Country	Name	City	State
China	City University of Hong Kong	Hong Kong

Sponsors (4)

Lead Sponsor	Collaborator
Dr. Annis Fung	Brooklyn College of the City University of New York, The University of Hong Kong, University of Pennsylvania

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Externalizing and internalizing behavior problems	The following instruments will be administered to both caregivers and the children to assess child behavior behavior problems (externalizing and internalizing); Adolescent self-reported measures include Reactive-Proactive Aggression Questionnaire (RPQ), Antisocial Personality Screening Device (APSD), Conduct and Oppositional Defiant Disorder Questionnaire (COD) and Child Behavior Checklist (CBCL - Attention and Anxiety/Depressed subscales only).	up to 12 months after initiation of trial: assessement at 0 months, 6 months (end of treatment) and 12 months (6 months post-tretament)
Secondary	Neurocognitive functioning	Neurocognitive functioning is assessed by the Tower of London. The Tower of London is an assessment tool to examine the functional anatomy of planning. It assesses high-order problem solving, specifically, executive planning abilities.	up to 12 months
Secondary	Psychophysiological functioning	Psychophysiological (attentional) functioning is assessed using EEG (P300 oddball task).	up to 12 months
Secondary	Emotional empathy	measured by a 10-items self-report instrument (CASES)	up to 12 months
Secondary	Grit	measured by an 8-item self-report instruments (GRIT)	up to 12 months