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Clinical Trials/NCT05453708
NCT05453708
Completed
Not Applicable

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

Walden University1 site in 1 country239 target enrollmentJune 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
Walden University
Enrollment
239
Locations
1
Primary Endpoint
Association between maternal folate intake during pregnancy and the occurrence of ASD in the offspring via questionnaire.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 16, 2022
End Date
January 22, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Haniff

Principal Investigator

Walden University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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