NCT02308930Unknown不适用
Effect of Dietary DHA Supplementation on Cognitive Performance and Growth in Chinese School Children: A Randomized Controlled Study
Sun Yat-sen University0 个研究点目标入组 106 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 106
- 主要终点
- Performance on Wisconsin card sorting test (WCST) and digit span test
研究概览
简要总结
The purpose of this study is to determine whether DHA supplement (in a daily dose of 300 mg) will improve the cognitive performance, associated metabolism and growth in normal children aged 6-12 years in primary schools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-12 years from primary schools.
- •Healthy as assessed by a physician.
- •Willing to participate in the study, consume the test product and perform all measurements including cognitive testing, blood drawing, urine samples, anthropometry and questionnaires.
- •Willing to maintain current dietary habits and intend to stay in the study area for ≥ one year.
- •Informed consent signed by parent or caregiver and oral consent given by child.
排除标准
- •Children with obvious mental and physical handicaps.
- •Children taking medication which interferes with study measurements (e.g., psychoactive medications or medications expected to affect behavior and learning).
- •Taking dietary supplements already.
- •Suffering major life events (immediate family death, parents divorce, etc.) within six months.
结局指标
主要结局
Performance on Wisconsin card sorting test (WCST) and digit span test
时间窗: 6 months
At baseline, 3 and 6 months cognitive tests will be administered, and the scores of Wisconsin card sorting test (WCST) and digit span test will be recorded.
次要结局
- DHA related metabolites and neurotransmitters (blood concentration of DHA related metabolites and neurotransmitters)(6 months)
研究者
Huilian Zhu
Professor
Sun Yat-sen University
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