Clinical trial NCT02334098: Omega-3 Supplementation and Behavior Problems
Official title: Omega-3 Supplementation and Behavior Problems in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Aggression
Antisocial Behavior
Antisocial Personality
Keywords: Aggression
Omega-3 supplementation
Neurocognition
Attention
Antisocial
Lead sponsor: City University of Hong Kong
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: The University of Hong Kong
name: Brooklyn College of the City University of New York
First posted: 2015-01-08
Enrollment: 324
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 parallel groups: (1) omega-3 + fruit juice (2) fruit juice only (3) controls (no drink).
Primary purpose: PREVENTION

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Externalizing and internalizing behavior problems
timeFrame: 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 outcomes:
measure: Neurocognitive functioning
timeFrame: up to 12 months
measure: Psychophysiological functioning
timeFrame: up to 12 months
measure: Emotional empathy
timeFrame: up to 12 months
measure: Grit
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: City University of Hong Kong
Study officials:
affiliation: City University of Hong Kong
name: Annis Fung, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: