An interventional study of Omega 3/6 fatty acids and Placebo in Reading Ability, sponsored by Göteborg University. Completed. Open to participants aged 9 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-27.
Sponsored by Göteborg University · Not applicable, Interventional, and Treatment
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)
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.
Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Participants received 3 capsules of Omega 3/6 fatty acids twice daily
Dietary Supplement: Omega 3/6 fatty acids
Participants received 3 capsules of identical placebo (palm oil) twice daily
Dietary Supplement: Placebo
Three Omega 3/6 capsules twice daily
Three placebo capsules twice daily
Change in reading ability
LOGOS test: Computerized test of several functions implicated in reading ability
Time frame: 0, 3 and 6 months
Change in ADHD symptom severity
ADHD-Rating Scale IV: Parent-rated questionnaire measuring the DSM-IV ADHD symptom criteria
Time frame: 0, 3 and 6 months
Change in learning ability
FTF scale: Parent-rated questionnaire, domain measuring problem scores in learning ability
Time frame: 0,3 and 6 months
Change in memory ability
FTF scale: Parent-rated questionnaire, domain measuring problem scores in memory ability
Time frame: 0, 3 and 6 months
Change in language/communication ability
FTF scale: Parent-rated questionnaire, domain measuring problem scores in language/communication ability
Time frame: 0,3 and 6 months
Change in problem solving ability
FTF scale: Parent-rated questionnaire, domain measuring problem scores in problem solving ability
Time frame: 0,3 and 6 months
Change in social ability
Social and Communication Disorders Checklist (SCDC): Parent-rated checklist measuring social ability
Time frame: 0,3 and 6 months
No study locations are listed for this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Göteborg University