An Examination of Changes in Urinary Metabolites With Use of Folinic Acid in Children With Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Aberrant Behavior Checklist (ABC) - Parent Reported Change
研究概览
简要总结
An examination of changes in urinary metabolites with use of folinic acid in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures and academic measures monthly at school with teachers and parents report.
详细描述
Children enrolled in Oak Hill School will enroll in this study and take folinic acid supplement twice a day for 12 weeks period. Behavioral measures and urinary metabolites will be collected pre and post treatment. Behavioral measures will be taken again at 16 weeks, after 4 weeks of not dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between ages 5 and 25
排除标准
- •Not currently taking folinic acid
研究组 & 干预措施
Open-label
In this open-label trial, all subjects will receive the twice daily dose of folinic acid. Folinic acid will be delivered in pill form at a weight-based dose.
干预措施: folinic acid (Drug)
结局指标
主要结局
Aberrant Behavior Checklist (ABC) - Parent Reported Change
时间窗: Baseline to Week 12
The Aberrant Behavior Checklist - parent reported version measures aberrant behavior in children and young adults. There are 58 questions.The scoring of one question can range from 0 (not a problem) to 3 (severe) points on a Likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time. Scoring from 0-3 Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3 Lower score indicates better performance.
Aberrant Behavior Checklist (ABC) - Teacher Reported Change
时间窗: Baseline to Week 12
The Aberrant Behavior Checklist - teacher reported version measures aberrant behavior in children and young adults. There are 58 questions. The scoring of ABC questions can range from 0 (not a problem) to 3 (severe) points on a likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time. Scoring from 0-3 Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3 Lower score indicates better performance.
次要结局
- Social Responsiveness Scale (SRS) - Parent Reported Change(Baseline to Week 12)
- Social Responsiveness Scale (SRS) - Teacher Reported Change(Baseline to Week 12)
- Pediatric Quality of Life (PedsQL) - Parent Reported Change(Baseline to Week 12)
研究者
Robert Hendren
Professor of Psychiatry
University of California, San Francisco