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| Name | Class |
|---|---|
| Vifor Pharma | INDUSTRY |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Participants received 3 capsules of Omega 3/6 fatty acids twice daily |
|
| Placebo | Placebo Comparator | Participants received 3 capsules of identical placebo (palm oil) twice daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3/6 fatty acids | Dietary Supplement | Three Omega 3/6 capsules twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in reading ability | LOGOS test: Computerized test of several functions implicated in reading ability | 0, 3 and 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27545509 | Derived | 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. |
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| Placebo |
| Dietary Supplement |
Three placebo capsules twice daily |
|
| 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 |