Clinical Trials Directory

Trials / Completed

CompletedNCT05453708

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

Status
Completed
Phase
Study type
Observational
Enrollment
239 (actual)
Sponsor
Walden University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSurveyOne 15-20-minute survey

Timeline

Start date
2022-06-16
Primary completion
2023-01-22
Completion
2023-01-22
First posted
2022-07-12
Last updated
2023-03-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05453708. Inclusion in this directory is not an endorsement.