Omega 3/6 Fatty Acids for Reading in Children

December 23, 2021 updated by: Göteborg University

Omega 3/6 Fatty Acids for Reading in Children: A Randomised, Double-blind, Placebo-controlled Trial in 9-year-old Mainstream Schoolchildren in Sweden

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active
Participants received 3 capsules of Omega 3/6 fatty acids twice daily
Dietary supplement: Omega 3/6 fatty acids
Three Omega 3/6 capsules twice daily
Placebo Comparator: Placebo
Participants received 3 capsules of identical placebo (palm oil) twice daily
Dietary supplement: Placebo
Three placebo capsules twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in reading ability
Time Frame: 0, 3 and 6 months
LOGOS test: Computerized test of several functions implicated in reading ability
0, 3 and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Vifor Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 13, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Actual)

December 27, 2021

Last Update Submitted That Met QC Criteria

December 23, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 381-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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