Nutritional and Dietary Treatment Study for Children/Adults With Autism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Reynolds Intellectual Assessment Scales
研究概览
简要总结
70 children and adults with autism spectrum disorders will be enrolled in a 1-year, single-blind treatment study. Assessments will be conducted at the beginning and end of the study, including measurements of nutritional, metabolic, and digestive status and assessments of autism severity and overall functioning. Half of the participants will be randomized into a treatment study, and half will be randomized to no changes in their current treatments. Treatments will be added in a sequential manner over 12 months, including vitamin/minerals, essential fatty acids, carnitine, digestive enzymes, and healthy, gluten-free, casein-free diets. A dedicated team of nutritionists, nurses, and physicians will support and monitor the participants throughout the study.
A group of 50 neurotypical children and adults, of similar age and gender, will be included for comparison.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Months 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria - Autism Group
- •Diagnosis of autism spectrum disorder (autism, PDD-NOS, or Asperger's) by a psychiatrist, psychologist, or developmental pediatrician
- •Verification of diagnosis by an ADOS evaluation (conducted by ASU staff)
- •Age of 2.5 years to 60 years
- •Enrollment Criteria - Non-autism Group
- •No diagnosed mental disorders, including autism spectrum disorders, ADHD, depression, anxiety, etc.
- •No first-degree relatives of individuals with autism (no siblings or parents)
- •Age of 2.5 years to 60 years -
排除标准
- •Exclusion Criteria - Autism Group
- •Major changes in behavioral or medical treatments in the previous two months, or intention to make such changes during the 12 months of the study.
- •Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months
- •Exclusion Criteria - Non-autism Group 1) Usage of nutritional supplements (vitamins, minerals essential fatty acids, carnitine) or special diets in the previous two months
结局指标
主要结局
Reynolds Intellectual Assessment Scales
时间窗: 12 months
Pre and post test of intellectual ability
Childhood Autism Rating Scale
时间窗: 12 months
Pre and post assessment of autism symptoms/severity
Vineland Adaptive Behavior Scale
时间窗: 12 months
Pre and post evaluation of adaptive behaviors
次要结局
未报告次要终点