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临床试验/NCT05453708
NCT05453708已完成不适用

Maternal Risk Factors for Autism Spectrum Disorders: A Case-Control Approach

Walden University1 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2022年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
239
试验地点
1
主要终点
Association between maternal folate intake during pregnancy and the occurrence of ASD in the offspring via questionnaire.

研究概览

简要总结

New research suggests that about 1 in 8 children may be diagnosed with an autism spectrum disorder (ASD) in the United States. This could be due to several reasons which remain unknown. This study invites mothers who have given birth to children in the United States to share their experiences with diet and supplementation during pregnancy. The purpose of this study is to understand the role of a mother's diet, social standing, and supplementation with folate or folic acid may have on her child's future development of autism. Comparisons will be made between mothers of children who have a child with an official ASD diagnosis from a clinician to mothers of children without an ASD diagnosis. Findings from this study can be used to help identify risk factors for ASD risk.

详细描述

Autism spectrum disorders (ASD) are a broad range of conditions characterized by social skills, repetitive behaviors, speech, and nonverbal communication challenges. Current prevalence estimates assert that 2.3% of children aged eight years or older live with an ASD, an increase from 1.5% in 2012. Estimates suggest that 1 in 44 children will be diagnosed with ASD. A child diagnosed on the spectrum faces several challenges and may require support from a caregiver, possibly across the lifespan. ASD etiology remains elusive, but research suggests there may be a link to genetic, environmental, and dietary risk factors while in-utero.

Further evidence suggests a folate/folic acid link during the peri-conceptual period. Prior folate/folic acid studies suggest a U-shaped relationship between maternal multivitamin supplementation. High maternal plasma folate and B12 levels are associated with the risk of ASD.

This study aims to apply a case-control approach to understand the role of folate/folic over- or under-supplementation, maternal sociodemographics, and diet during pregnancy on ASD risk.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers 18 years or older with a child aged 3-12 years who have an official ASD diagnosis from a clinician
  • Mothers 18 years or older of children aged 3-12 years who do not have an ASD diagnosis so comparisons can be made between groups

排除标准

  • Mothers outside of the United States
  • Mothers less than 18 years of age
  • Mothers who have not given birth to their child or who used a surrogate

结局指标

主要结局

Association between maternal folate intake during pregnancy and the occurrence of ASD in the offspring via questionnaire.

时间窗: 42 weeks gestation

Number of participants with a child diagnosed with ASD who used multivitamins or folate/folic acid supplements during pregnancy as assessed by the questionnaire.

次要结局

  • Association between mother's co-morbidities and the occurrence of ASD in offspring via questionnaire.(42 weeks gestation)

研究者

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

Michael Haniff

Principal Investigator

Walden University

研究点 (1)

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