Open Label Clinical Trial of Vitamin D Dosage Tolerability, and Effect on Behavioral Measures in Children With Autism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Clinical Global Impression Scale - Improvement (CGI-I)
研究概览
简要总结
Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation, titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients.
The study will determine if initial safety and effect estimates predict that a double blind randomized control trial (RCT) with a larger set of patients will be worthwhile in the localization of this treatment aimed at improving the symptoms of ASDs.
Exploratory: to determine efficacy of high dose D3 replacement for improvement in the core symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior, and sleep, as determined by parental and clinical evaluation scales.
详细描述
data is still being collected
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 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Autism from DSM-IV TR and ADOS
- •Moderate but less than severe on CGI-Severity scale
- •ZRT 25(OH)D blood spot test < 30 ng/ml
- •Age 3-8 years old
排除标准
- •Developmental delays prior to 12 months of age
- •history of head trauma
- •seizure in the past year
- •bleeding disorder
- •history of kidney or liver disease
- •clinically significant low white blood cell count
- •PDD-NOS, Rett's syndrome, Childhood Disintegrative Disorder or Fragile X syndrome
- •current supplementation with Vitamin D, Vitamin A or cod-liver oil
研究组 & 干预措施
Liquid Vitamin D
干预措施: Liquid Vitamin D (Drug)
结局指标
主要结局
Clinical Global Impression Scale - Improvement (CGI-I)
时间窗: Baseline and 12 weeks from Baseline
Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved.
次要结局
未报告次要终点