跳至主要内容
临床试验/NCT00577447
NCT00577447已完成不适用

A Randomized, Double-Blind, Placebo-Controlled Trial of Docosahexaenoic Acid Supplementation in Children With Autism

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2005年10月最近更新:
适应症

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

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)

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (2)

Loading locations...

相似试验