Omega 3/6 Fatty Acids for Reading in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Reading Ability

Intervention / Treatment
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* Dietary Supplement: Omega 3/6 fatty acids
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Participants received 3 capsules of Omega 3/6 fatty acids twice daily | Dietary Supplement: Omega 3/6 fatty acids<br>* Three Omega 3/6 capsules twice daily<br>|
| Placebo Comparator: Placebo<br>Participants received 3 capsules of identical placebo (palm oil) twice daily | Dietary Supplement: Placebo<br>* Three placebo capsules twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

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