NCT04845776已完成不适用
Vitamin/Mineral Supplement for Children With Autism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Parent Global Impressions of Autism
研究概览
简要总结
This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism.
详细描述
This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism. There will be pre/post assessments of autism symptoms,GI symptoms, and laboratory tests. Typically-developing children will be assessed at baseline only (no treatments) for comparison.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child age 3-17 years (up until 18th birthday)
- •Previous diagnosis of ASD by a psychiatrist, psychologist, or developmental pediatrician
- •Verification of diagnosis by ASU staff using the Autism Diagnostic Interview-Revised.
- •No changes in any medical, nutritional, dietary, behavior, or other treatment in the last three months, and a willingness to avoid any changes during the study
- •Participant is able to wear a mask during the short visit for the blood draw.
排除标准
- •Parent/guardian is unable to read or speak English fluently.
- •Use of a vitamin/mineral supplement in the past 3 months
- •Previous adverse reaction to a vitamin/mineral supplement
- •Unstable, poor health; seizure disorder that is not responsive to treatment or not on stable management or complex type; or other health conditions that would significantly increase their risk of adverse effects (per physician clinical judgement)
- •Use of any medication which has a contra-indication for one of the ingredients in the vitamin/mineral supplement
- •A major single-gene disorder such as Fragile X, Down's Syndrome.
- •Major brain malformation
- •Tube feeding
- •Current participation in other clinical trials
- •Females who are pregnant or who are sexually active without effective birth control.
- •Clinically significant abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential.
- •Psychotropic medication use which can affect neurotransmitter levels/function - Current or within past 2 months
结局指标
主要结局
Parent Global Impressions of Autism
时间窗: assessed at the 3 months (end of treatment)
a 20-item questionnaire with a Likert scale assessing changes in symptoms
次要结局
未报告次要终点
研究者
研究点 (2)
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