Treating Oxidative Stress and the Metabolic Pathology of Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Behavioral test scores
研究概览
简要总结
Hypothesis: Many children with autism have impaired methylation and antioxidant/detoxification capacity and chronic oxidative stress. A targeted nutritional intervention that is designed to correct the metabolic imbalance will normalize their metabolic profile and improve measures of autistic behavior.
详细描述
Hypothesis and Specific Aims Hypothesis: A significant proportion of autistic children have impaired methylation and antioxidant/detoxification capacity resulting in chronic oxidative stress. Targeted nutritional intervention that is designed to correct the metabolic imbalance will significantly improve their metabolic profile and improve measures of autistic behavior.
If proven correct, this hypothesis could generate specific biomarkers to define individual behavioral phenotypes within the autism spectrum and indicate targeted treatment options to reduce and possibly prevent the clinical and behavioral manifestations of autism.
Specific Aim 1. To screen children with a diagnosis of autism for evidence of impaired methylation (↓SAM/SAH) and impaired antioxidant capacity (↓GSH/GSSG)
Specific Aim 2. Children who exhibit evidence of impaired methylation and antioxidant capacity will be randomized into a double blind placebo-controlled parallel group trial of targeted nutritional intervention designed to correct metabolic deficiencies and imbalance and to improve scores on standardized behavioral evaluation tests.
The two specific aims (Study Phase 1 and 2 respectively) are designed to increase the understanding of the metabolic factors that contribute to development and clinical manifestations of autism. We anticipate that the knowledge gained from the successful achievement of our aims will provide an important new metabolic dimension to early diagnosis and clinical management of autistic children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADOS and DSM-IV (299.0) diagnosis of Autistic Disorder
- •Both sexes
- •Age range 3-7
排除标准
- •Pervasive Developmental Disorder, Not Otherwise Specified (PDD-NOS)
- •Asperger's
- •Rett syndrome
- •Fragile X
- •Tuberous sclerosis or other genetic conditions associated with autism
- •Frequent seizures
- •Recurrent or current infection
- •Severe gastrointestinal distress
- •Recent supplement use
结局指标
主要结局
Behavioral test scores
时间窗: 4 months
次要结局
- Plasma metabolic profile(4 months)
