NCT04498078已完成不适用
The Effects of Creatine Supplementation in Autism Spectrum Disorder: a Randomized Placebo-controlled Trial
University of Novi Sad, Faculty of Sport and Physical Education1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Brain creatine change
研究概览
简要总结
Autism Spectrum Disorder (ASD) is accompanied by reduced levels of total creatine in right temporal-parietal junction and other brain regions of interest, and addressing this deficit by exogenous administration of creatine may have beneficial effects on brain metabolism and disease-specific clinical symptoms in patients suffering from ASD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10 years and above
- •Informed consent signed by a parent or legal guardian or legal representative
- •Diagnostic and Statistical Manual of Mental Disorders-IV criteria for ASD.
排除标准
- •Pregnant or nursing female patients
- •Non-pharmacologic therapy
- •Current diagnosis of other mental disorder
研究组 & 干预措施
Creatine
Experimental
Twenty grams per day b.i.d.
干预措施: Creatine (Dietary Supplement)
结局指标
主要结局
Brain creatine change
时间窗: Change from Baseline Brain Creatine Levels at 6 Months
Monitor change in brain creatine levels by magnetic resonance imaging
次要结局
- Brain N-acetylaspartate change(Change from Baseline Brain N-acetylaspartate Levels at 6 Months)
- Autism Treatment Evaluation Checklist (ATEC) score(Change from Baseline ATEC Scores at 6 Months)
研究者
研究点 (1)
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