Clinical trial NCT02557477: Omega 3/6 Fatty Acids for Reading in Children
Official title: Omega 3/6 Fatty Acids for Reading in Children: A Randomised, Double-blind, Placebo-controlled Trial in 9-year-old Mainstream Schoolchildren in Sweden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reading Ability
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
First posted: 2015-09-23
Enrollment: 154
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in reading ability
timeFrame: 0, 3 and 6 months
Secondary outcomes:
measure: Change in ADHD symptom severity
timeFrame: 0, 3 and 6 months
measure: Change in learning ability
timeFrame: 0,3 and 6 months
measure: Change in memory ability
timeFrame: 0, 3 and 6 months
measure: Change in language/communication ability
timeFrame: 0,3 and 6 months
measure: Change in problem solving ability
timeFrame: 0,3 and 6 months
measure: Change in social ability
timeFrame: 0,3 and 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Johnson M, Fransson G, Ostlund S, Areskoug B, Gillberg C. Omega 3/6 fatty acids for reading in children: a randomized, double-blind, placebo-controlled trial in 9-year-old mainstream schoolchildren in Sweden. J Child Psychol Psychiatry. 2017 Jan;58(1):83-93. doi: 10.1111/jcpp.12614. Epub 2016 Aug 22.