## Protocol Section
### Identification Module
**NCT ID:** NCT02016079

**Brief Title:** Effect of Omega-3 Supplementation on Child Behavior Problems

**Official Title:** Randomized Controlled Trial of Omega-3 on Child Behavior Problems

#### Organization Study ID Info
**ID:** JCHP-01
#### Organization
**Class:** OTHER
**Full Name:** Joint Child Health Project, Mauritius
#### Secondary ID Infos
**Domain:** JCHP
**ID:** JCHP-N3
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-12-19

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-12-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Start Date
**Date:** 2010-03

**Status Verified Date:** 2013-12

#### Study First Post Date
**Date:** 2013-12-19
**Type:** ESTIMATED
**Study First Submit Date:** 2013-12-10
**Study First Submit QC Date:** 2013-12-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Joint Child Health Project, Mauritius

#### Responsible Party

**Investigator Affiliation:** Joint Child Health Project, Mauritius

**Investigator Full Name:** Tashneem Moohamed

**Investigator Title:** National Director, JCHP

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children.

**Detailed Description:** This study consists of a randomized, placebo-controlled, double-blind trial of omega-3 on behavior problems in children. All behavior problem outcomes were assessed, although the primary focus was on antisocial and aggressive behavior.

### Conditions Module

**Conditions:**

- Antisocial

- Aggressive

- Externalizing Behavior Problems

- Internalizing Behavior Problems

**Keywords:**

- randomized controlled trial

- omega-3

- nutrition

- behavior problems

- externalizing

- internalizing

- antisocial

- aggressive

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ACTUAL

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** a fruit drink containing omega-3

**Intervention Names:**

- Dietary Supplement: omega-3

**Label:** Omega-3

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** the same fruit drink given in the experimental arm, but not containing omega-3

**Label:** Fruit drink

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Omega-3

**Description:** 200 ml fruit drink containing omega-3

**Name:** omega-3

**Other Names:**

- Smartfish

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** The outcome measure assessed internalizing and externalizing behavior problems in children

**Measure:** Child Behavior Checklist

**Time Frame:** 6 months

**Description:** A self-report measure of reactive and proactive forms of aggressive behavior

**Measure:** Reactive-Proactive Aggression Questionnaire

**Time Frame:** 6 months

**Description:** A measure of antisocial personality, with a total score and three subscales: callous-unemotional, impulsivity, narcissism

**Measure:** Antisocial Personality Screening Device

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** estimate of IQ

**Measure:** WISC

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* child
* age between 8 and 16 years
* residing in the community

Exclusion Criteria:

* fish allergy
* diagnosed mental disorder
* mental retardation
* on medication that may modify lipid metabolism
* extensive use of nutritional supplements within the previous 3 months

**Maximum Age:** 16 Years

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Quatre Bornes

**Country:** Mauritius

**Facility:** Joint Child Health Project

#### Overall Officials

**Official 1:**

**Affiliation:** Joint Child Health Project

**Name:** Tashneem Moohamed, BSc

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Action Research Program, Educational Priroity Areas, Mauritius

**Name:** Cyril Dalais, MSc

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Raine A, Portnoy J, Liu J, Mahoomed T, Hibbeln JR. Reduction in behavior problems with omega-3 supplementation in children aged 8-16 years: a randomized, double-blind, placebo-controlled, stratified, parallel-group trial. J Child Psychol Psychiatry. 2015 May;56(5):509-20. doi: 10.1111/jcpp.12314. Epub 2014 Aug 22.

**PMID:** 25146492

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000096762

- Term: Aberrant Motor Behavior in Dementia

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M85

- Name: Problem Behavior

- Relevance: HIGH

- As Found: Behavior Problem

- ID: M3724

- Name: Aggression

- Relevance: HIGH

- As Found: Aggressive

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M3259

- Name: Aberrant Motor Behavior in Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000374

- Term: Aggression

- ID: D000066553

- Term: Problem Behavior

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T415

- Name: Omega 3 Fatty Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
