Omega-3 Supplementation and Behavior Problems

NCT02334098 | Completed Phase 2 DMC

• 1 other identifier: GRF-11402514
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this project are as follows:

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

Conditions

Aggression; Antisocial Behavior; Antisocial Personality

Keywords

Aggression; Omega-3 supplementation; Neurocognition; Attention; Antisocial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Neurocognitive functioning

  up to 12 months

• Psychophysiological functioning

  up to 12 months

• Emotional empathy

  up to 12 months

• Grit

  up to 12 months

Study Arms (3)

Omega-3 supplemented drink

EXPERIMENTAL

A 200 ml. drink product with 1.1 grams of omega-3 from Smartfish (Smartfish: Forsiden in Norway).

Dietary Supplement: Omega-3 supplemented drink

Placebo Drink

PLACEBO COMPARATOR

exactly the same fruit drink contained in the same packaging, but will contain no omega-3.

Dietary Supplement: Smartfish

treatment-as-usual controls

NO INTERVENTION

No drinks are taken.

Interventions

Omega-3 supplemented drink DIETARY_SUPPLEMENT

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.

Omega-3 supplemented drink

Smartfish DIETARY_SUPPLEMENT

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).

Placebo Drink

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children and adolescents between the age 8 and 18

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Annis Fung: lead
• University of Pennsylvania: collaborator
• The University of Hong Kong: collaborator
• Brooklyn College of the City University of New York: collaborator

Study Sites (1)

City University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Aggression; Antisocial Personality Disorder

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Personality Disorders; Mental Disorders

Study Officials

• Annis Fung, Ph.D.

  City University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: all participants and research assistants are blind to condition for the two fruit juice groups
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 3 parallel groups: (1) omega-3 + fruit juice (2) fruit juice only (3) controls (no drink).

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: January 8, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

CN (1)