Impact of Serum Vitamin D Correction on the Inflammatory Markers and Habilitation Outcome in Children With Autism Spectrum Disorder
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- language ability test
研究概览
简要总结
The aim of this work is to study the adjuvant effect of vitamin D supplementation on inflammatory marker (IL4) and habilitation outcome in children with Autism Spectrum Disorder in order to evaluate its efficiency as a treatment option based on correction of immune dysfunction.
详细描述
Vitamin D is one of environmental factors potentially modulating brain development and functioning. Vitamin D3 deficiency during pregnancy and early childhood is suggested to be one of several risk factors for development of ASD in genetically predisposed individuals (Cies´lin´ska et al., 2017). Many studies e.g (Eyles et al., 2013; Grant and Sole, 2009; Noriega and Savelkoul, 2014) suggested that vitamin D has an important role as a neuroactive steroid, which can affect neuronal differentiation, axonal connectivity and brain structure and function. Vitamin D has been increasingly recognized for its immunomodulatory role and has been implicated in the pathogenesis of autoimmune disorders. Also it has numerous and dynamic effects on the immune system, ranging from altering T cell responses and regulating cytokine pathways (Kocˇovská et al., 2017). So from this point of view, this study will be conducted to show adjuvant effect of vitamin D supplementation on ASD children at clinical level and inflammatory marker (IL4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 2 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Delayed language development due to ASD.
- •Good nutritional status (Normal weight and height using growth charts, no Anemia and no clinical evidence of vitamin deficiency).
- •Normal hearing and vision.
排除标准
- •History of vitamin D supplementation, drugs modulating immune system as steroid and drug formula containing vitamin D as cod liver oil.
- •Known chronic disease.
- •Known neurological disorders or psychiatric disorders.
- •Known autoimmune or gastrointestinal disorders.
研究组 & 干预措施
Vitamin D therapy and habilitation
40 ASD children receiving Vitamin D therapy and habilitation
干预措施: Vitamin D (Drug)
Vitamin D therapy and habilitation
40 ASD children receiving Vitamin D therapy and habilitation
干预措施: Habilitation (Other)
Habilitation
40 ASD children receiving habilitation
干预措施: Habilitation (Other)
结局指标
主要结局
language ability test
时间窗: 4 months
language test for assessment of language age
Inflammatory marker
时间窗: 4 months
Assessment of serum interleukin 4 by ELISA technique
CARS questionnaire for assessment of ASD severity
时间窗: 4 months
CARS questionnaire for assessment of ASD severity
Serum vitamin D
时间窗: 6 weeks
Assessment of serum vitamin D by ADVIA Centaur® Vitamin D Total (VitD) assay
次要结局
未报告次要终点
研究者
Amira Mohamed Mansour
Assistant lecturer
Mansoura University
