Omega 3/6 Fatty Acids for Reading in Children

Göteborg University

Status: Completed

Conditions: Reading Ability

Treatments: Dietary Supplement: Omega 3/6 fatty acids; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02557477

381-09

Details and patient eligibility

About

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)

Full 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.

Enrollment: 154 patients

Sex: All

Ages: 9 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

Participants received 3 capsules of Omega 3/6 fatty acids twice daily

Treatment:

Dietary Supplement: Omega 3/6 fatty acids

Placebo

Placebo Comparator group

Description:

Participants received 3 capsules of identical placebo (palm oil) twice daily

Treatment:

Dietary Supplement: Placebo