Omega 3/6 Fatty Acids for Reading in Children: A Randomised, Double-blind, Placebo-controlled Trial in 9-year-old Mainstream Schoolchildren in Sweden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 主要终点
- Change in reading ability
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mainstream schoolchildren in the 3rd school year (aged 9-10 years).
排除标准
- •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.
结局指标
主要结局
Change in reading ability
时间窗: 0, 3 and 6 months
LOGOS test: Computerized test of several functions implicated in reading ability
次要结局
- Change in ADHD symptom severity(0, 3 and 6 months)
- Change in learning ability(0,3 and 6 months)
- Change in memory ability(0, 3 and 6 months)
- Change in language/communication ability(0,3 and 6 months)
- Change in problem solving ability(0,3 and 6 months)
- Change in social ability(0,3 and 6 months)