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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05453708
Enrollment
239
Registered
2022-07-12
Start date
2022-06-16
Completion date
2023-01-22
Last updated
2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Autism Spectrum Disorder, Autistic Disorder, Diet; Deficiency, Diet, Healthy, Folate Deficiency, Folic Acid Deficiency, Folic Acid Overdose, Pregnancy Related

Keywords

Diet, Maternal diet, Autism pregnancy, Perinatal, Folate, Folic Acid

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.

Interventions

OTHERSurvey

One 15-20-minute survey

Sponsors

Walden University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Association between maternal folate intake during pregnancy and the occurrence of ASD in the offspring via questionnaire.42 weeks gestationNumber of participants with a child diagnosed with ASD who used multivitamins or folate/folic acid supplements during pregnancy as assessed by the questionnaire.

Secondary

MeasureTime frameDescription
Association between mother's co-morbidities and the occurrence of ASD in offspring via questionnaire.42 weeks gestationNumber of participants with a child diagnosed with ASD who also have a comorbidity or developed a comorbidity during pregnancy as assessed by the questionnaire.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026