Efficacy of Nutritional Supplements on Children With Autism Spectrum Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Social Responsiveness Scale, Second Edition (SRS-2)
研究概览
简要总结
The goal of this clinical trial is to learn if nutritional supplements could alleviate the clinical symptoms in children with autism spectrum disorder. It will also learn about the safety of these nutritional supplements.
Researchers will compare the combination of nutritional supplements and behavioral intervention, to behavioral intervention alone, to see if nutritional supplements work to treat autism.
Participants will receive the combination of nutritional supplements and behavioral interventions or solely behavioral interventions for 3 months. And they will visit the clinic at the beginning of the trial (baseline) and after the 3-month intervention period for examinations.
详细描述
This is an open-label clinical trial aimed at investigating whether nutritional supplements could alleviate the clinical symptoms in children with autism spectrum disorder. Participants will be randomly assigned to either the experimental group or the control group.
Participants in the experimental group will receive the combination of nutritional supplements, including Vitamin B1, Vitamin B2, folic acid, Mecobalamin, Vitamin D3, Choline, and Coenzyme Q10, along with the behavioral interventions, for a period of three months. Participants in the control group will only undergo behavioral interventions.
during the intervention period, the clinical symptoms, metabolomics of bio-specimens, and potential adverse effects will be closely monitored.
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 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 2.5 and 6 years old
- •Meeting the ASD diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- •Meeting the ASD diagnostic criteria of the Diagnostic Observational Scale for Autism, Second Edition (ADOS-2）
- •CARS total score ≥ 30
- •Obtaining informed consent from the legal guardian
排除标准
- •History of neurological diseases such as epilepsy
- •History of congenital diseases such as hearing, visual impairment
- •Diagnosed with metabolic disorders such as hypophosphatemic rickets
- •Diagnosed with genetic or chromosomal abnormalities
- •Brain structural abnormalities detected by MRI which required surgical intervention
- •Currently participating in other clinical trials
- •Received any new intervention within 8 weeks prior to enrollment
研究组 & 干预措施
Nutritional supplements plus treatment as usual (TAU)
Participants in experimental group with received nutritional supplements, along with treatments as usual (i.e. behavioral interventions)
干预措施: Nutritional supplements (Dietary Supplement)
Treatment as usual (TAU)
Participants in the control group will undergo treatments as usual, such as behavioral interventions
干预措施: Treatment as usual (TAU) (Behavioral)
Nutritional supplements plus treatment as usual (TAU)
Participants in experimental group with received nutritional supplements, along with treatments as usual (i.e. behavioral interventions)
干预措施: Treatment as usual (TAU) (Behavioral)
结局指标
主要结局
Social Responsiveness Scale, Second Edition (SRS-2)
时间窗: From enrollment to the end of treatment at 3 months
Social Responsiveness Scale, Second Edition (SRS-2) is a scale used to evaluate the presence and severity of social impairment. The scores of the SRS-2 rate from 0 to 195, and higher scores indicate more severe symptoms. Changes of the SRS-2 scores from baseline to 3 month after treatment will be analyzed to assess the effect of the intervention on children with autism spectrum disorder.
次要结局
- Chinese Communicative Development Inventory (CCDI)(From enrollment to the end of treatment at 3 months)
- Clinical Global Impressions Scale (CGI)(From enrollment to the end of treatment at 3 months)
- Childhood Autism Rating Scale (CARS)(From enrollment to the end of treatment at 3 months)
- Aberrant Behavior Checklist (ABC)(From enrollment to the end of treatment at 3 months)
研究者
Fei Li
Chief Physician, Doctoral Supervisor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine