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

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Avitaminosis Child Development Disorders, Pervasive Deficiency Diseases Diet, Healthy Diet; Deficiency Folate Deficiency Folic Acid Deficiency Folic Acid Overdose Malnutrition Mental Disorders Neurodevelopmental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Pregnancy Related Vitamin B Deficiency

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Walden University

Minneapolis, Minnesota, 55401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

One 15-20-minute survey

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.

Time frame: 42 weeks gestation

Number of participants with a child diagnosed with ASD who also have a comorbidity or developed a comorbidity during pregnancy as assessed by the questionnaire.

Sponsors and collaborators

Lead sponsor

Walden University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jul 12, 2022
Registry last updated: Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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