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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05453708
Study type	Observational
Source	Walden University
Contact
Status	Completed
Phase
Start date	June 16, 2022
Completion date	January 22, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms