Omega 3/6 Fatty Acids for Reading in Children

Not Applicable

Completed

• Conditions: Reading Ability
• Interventions: Dietary Supplement: Omega 3/6 fatty acids; Dietary Supplement: Placebo

• Registration Number: NCT02557477
• Lead Sponsor: Göteborg University

Brief Summary

The primary objective was to assess whether supplementation of Omega 3/6 fatty acids improves mainstream schoolchildren's reading ability. The secondary objective was to assess whether Omega 3/6 improves cognitive functions such as attention, memory, learning, language/communication, problem solving and social ability.This was a 3-month randomised, double-blind, placebo-controlled study followed by one-way crossover (placebo to active treatment) for an additional 3 months. Mainstream schoolchildren aged 9-10 years were initially randomised to receive three Omega 3/6 capsules twice daily or identical placebo. All outcome measures were assessed at baseline, 3 months and 6 months. The primary outcome measure was the LOGOS test, a comprehensive test battery for evaluating reading abilities. Secondary outcome measures were the parent-rated Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV, 5-15 scale (domains of learning, memory, language/communication and problem solving); Social and Communication Disorders Checklist (to evaluate social ability)

Detailed Description

This was a 3-month randomized, double-blind, placebo-controlled study (Period 1) followed by one-way crossover (placebo to active treatment) for an additional 3 months (Period 2). Participants were randomized to receive three Omega 3/6 capsules twice daily (corresponding to a daily dose of 558 mg EPA, 174 mg DHA, and 60 mg gamma-linolenic acid) or identical placebo capsules (palm oil). All daily doses were taken at home supervised by the parents. All outcome measures were assessed at baseline and at the 3- and 6-month follow-up visits. The participants were mainstream schoolchildren in the 3rd school year (aged 9-10 years). Exclusion criteria were continuous supplementation of Omega-3 fatty acids for periods longer than 1 month during the previous year, significant medical conditions (e.g. diabetes, epilepsy), intellectual disability, attention-deficit hyperactivity disorder (ADHD) diagnosis, psychoactive medication, or substance use.

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2015-09-13
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• mainstream schoolchildren in the 3rd school year (aged 9-10 years).

Exclusion Criteria

• continuous supplementation of Omega-3 fatty acids for periods longer than 1 month during the previous year
• significant medical conditions (e.g. diabetes, epilepsy)
• intellectual disability
• attention-deficit hyperactivity disorder (ADHD) diagnosis, psychoactive medication, or substance use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Omega 3/6 fatty acids	Participants received 3 capsules of Omega 3/6 fatty acids twice daily
Placebo	Placebo	Participants received 3 capsules of identical placebo (palm oil) twice daily

Primary Outcome Measures

Name	Time	Method
Change in reading ability	0, 3 and 6 months	LOGOS test: Computerized test of several functions implicated in reading ability

Secondary Outcome Measures

Name	Time	Method
Change in problem solving ability	0,3 and 6 months	FTF scale: Parent-rated questionnaire, domain measuring problem scores in problem solving ability
Change in ADHD symptom severity	0, 3 and 6 months	ADHD-Rating Scale IV: Parent-rated questionnaire measuring the DSM-IV ADHD symptom criteria
Change in learning ability	0,3 and 6 months	FTF scale: Parent-rated questionnaire, domain measuring problem scores in learning ability
Change in memory ability	0, 3 and 6 months	FTF scale: Parent-rated questionnaire, domain measuring problem scores in memory ability
Change in language/communication ability	0,3 and 6 months	FTF scale: Parent-rated questionnaire, domain measuring problem scores in language/communication ability
Change in social ability	0,3 and 6 months	Social and Communication Disorders Checklist (SCDC): Parent-rated checklist measuring social ability