NCT02508922已完成不适用
Vitamin D3 for Autism Spectrum Disorder: a Randomized, Double-blind, Placebo-controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Change from baseline in stereotypic behaviour from the aberrant behaviour checklist
研究概览
简要总结
To build on a recent case study and open label trial, the investigators want to find out if vitamin D supplementation can influence behavioural and core symptoms of autism.
详细描述
The investigators will assess behavioural and core symptoms of autism before and after 20 weeks of vitamin D supplementation in a double-blind, placebo-controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive autism diagnostic observation schedule
- •Stable medication regimen
- •Tolerate phlebotomy
排除标准
- •Unstable or very severe autism
- •Renal/liver/gastrointestinal disease
结局指标
主要结局
Change from baseline in stereotypic behaviour from the aberrant behaviour checklist
时间窗: Day 1 and day 140
A subscale derived from the validated aberrant behaviour checklist
次要结局
- Change from baseline in serum 25-hydroxyvitamin D levels(Day 1 and day 140)
- Change from baseline in serum calcium levels, corrected for albumin(Day 1 and day 140)
- Change from baseline in aberrant behaviour checklist(Day 1 and day 140)
- Change from baseline in cytokines(Day 1 and day 140)
- Change from baseline in autoimmune markers(Day 1 and day 140)
- Change from baseline in behaviour Assessment System for Children - Second Edition(Day 1 and day 140)
- Change from baseline in repetitive behavior Scale - Revised(Day 1 and day 140)
- Change from baseline in Social Responsiveness Scale(Day 1 and day 140)
- Change from baseline in Developmental Disabilities-Children's Global Assessment Scale(Day 1 and day 140)
- Change from baseline in Vitamin D and Sun Questionnaire(Day 1 and day 140)
研究者
Conor Kerley
Dietitian and Nutrition Scientist
University of Dublin, Trinity College
研究点 (6)
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