Effect of Omega-3 Supplementation on Child Behavior Problems

Joint Child Health Project, Mauritius

Status and phase: Completed; Phase 3; Phase 2

Conditions: Externalizing Behavior Problems; Aggressive; Internalizing Behavior Problems; Antisocial

Treatments: Dietary Supplement: omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT02016079

JCHP-01

JCHP-N3 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Omega-3

Experimental group

Description:

a fruit drink containing omega-3

Treatment:

Dietary Supplement: omega-3

Fruit drink

Placebo Comparator group

Description:

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