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临床试验/NCT05595044
NCT05595044招募中1 期

Impact of Serum Vitamin D Correction on the Inflammatory Markers and Habilitation Outcome in Children With Autism Spectrum Disorder

Mansoura University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年10月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

40 ASD children receiving Vitamin D therapy and habilitation

干预措施: Vitamin D (Drug)

Vitamin D therapy and habilitation

Experimental

40 ASD children receiving Vitamin D therapy and habilitation

干预措施: Habilitation (Other)

Habilitation

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Mohamed Mansour

Assistant lecturer

Mansoura University

研究点 (1)

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