New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Oxidative Stress
研究概览
简要总结
The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in:
- improvement of nutritional status in some children/adults with autism, and
- reduction of some of the symptoms of autism in some children
详细描述
The major goal of this study is to determine the effect of this vitamin/mineral supplement on levels of vitamins, minerals, neurotransmitters, and biomarkers for nutritional deficiencies. The study design is a randomized, double-blind, placebo-controlled. Blood and urine measurements will be measured at the beginning of the study in children with autism and typical children. Then, the children with autism will be given the supplement or placebo for 12 weeks, and then their blood and urine will be re-measured.
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 3-60 years old;
- •Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional
- •Control Group: in good mental and physical health, and no siblings with autism spectrum disorders, and no evidence of Attention Deficit Disorder by parent report
排除标准
- •Usage of a vitamin/mineral supplement in the last 2 months
- •Current use of any chelation treatment
研究组 & 干预措施
Placebo Group
Liquid placebo with identical packaging and flavoring to the real supplement.
干预措施: Liquid Placebo (Other)
Vitamin/Mineral Supplement Group
Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders.
干预措施: Multi-Vitamin/Mineral Supplement (Dietary Supplement)
结局指标
主要结局
Oxidative Stress
时间窗: End of Study (after 12 weeks of treatment)
Level of plasma nitrotyrosine
Oxidative Stress
时间窗: Beginning of study (day 0)
Level of Plasma Nitrotyrosine
次要结局
- Parent Global Impressions - Revised(End of study (12 weeks))