A Randomized, Double-Blind, Placebo-Controlled Trial of Docosahexaenoic Acid Supplementation in Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Clinical Global Impressions-Improvement Scale
研究概览
简要总结
The purpose of this study is to test the hypothesis that dietary supplementation with the omega-3 fatty acid docosahexaenoic acid (DHA) improves the behavior of children with autism.
详细描述
Autism is a neurodevelopmental disability with an increasing prevalence. Traditional medicine does not offer any cures for autism; thus, many parents of children with autism are attracted to complementary and alternative therapies, one of which is dietary supplementation with the long chain polyunsaturated omega-3 fatty acid, docosahexaenoic acid (DHA). DHA is a critical structural lipid of brain cell membranes and differences in brain DHA content may influence synaptic function, particularly in nutritionally-sensitive areas of the brain, such as the cerebellum and hippocampus, which may be brain structures involved in the etiology of autism. This study is a randomized, double-blind, placebo-controlled trial investigating whether DHA supplementation is an effective treatment for children with autism. Eighty children with autism will be randomized to receive 200mg of DHA or placebo for 6 months. Outcome variables will include total plasma fatty acid patterns and scores on parent and investigator-completed behavioral and developmental rating scales at baseline and after 3 and 6 months of supplementation. Differences between groups after 6 months will be evaluated using regression methods. Regression analysis will be used to detect correlations between plasma total fatty acid DHA contents and scores on the various outcome measures. Results from this study will either provide evidence for a breakthrough biomedical treatment alternative for children with autism or evidenced-based advice to desperate parents in regard to their choices of potential treatments for their children with autism
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
- 3 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-IV criteria for autistic disorder
- •Age 3 to 10 years
排除标准
- •Use of a dietary supplement containing DHA within 90 days of study inclusion
- •Medical history of a disorder of lipid metabolism
结局指标
主要结局
Clinical Global Impressions-Improvement Scale
时间窗: 6 months
次要结局
- Aberrant Behavior Checklist(6 months)
- Behavior Assessment Scale for Children(6 months)
- Child Development Inventory(6 months)
