Skip to content

Omega 3/6 Fatty Acids for Reading in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02557477
Enrollment
154
Registered
2015-09-23
Start date
2010-03-31
Completion date
2012-12-31
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reading Ability

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.

Interventions

DIETARY_SUPPLEMENTOmega 3/6 fatty acids

Three Omega 3/6 capsules twice daily

DIETARY_SUPPLEMENTPlacebo

Three placebo capsules twice daily

Sponsors

Vifor Pharma
CollaboratorINDUSTRY
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 10 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in reading ability0, 3 and 6 monthsLOGOS test: Computerized test of several functions implicated in reading ability

Secondary

MeasureTime frameDescription
Change in learning ability0,3 and 6 monthsFTF scale: Parent-rated questionnaire, domain measuring problem scores in learning ability
Change in memory ability0, 3 and 6 monthsFTF scale: Parent-rated questionnaire, domain measuring problem scores in memory ability
Change in ADHD symptom severity0, 3 and 6 monthsADHD-Rating Scale IV: Parent-rated questionnaire measuring the DSM-IV ADHD symptom criteria
Change in problem solving ability0,3 and 6 monthsFTF scale: Parent-rated questionnaire, domain measuring problem scores in problem solving ability
Change in social ability0,3 and 6 monthsSocial and Communication Disorders Checklist (SCDC): Parent-rated checklist measuring social ability
Change in language/communication ability0,3 and 6 monthsFTF scale: Parent-rated questionnaire, domain measuring problem scores in language/communication ability

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026