Clinical trial NCT05453708: Maternal Risk Factors for Autism Spectrum Disorders: A Case-Control Approach
Official title: Maternal Risk Factors for Autism Spectrum Disorders: A Case-Control Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism
Autism Spectrum Disorder
Autistic Disorder
Pregnancy Related
Diet, Healthy
Diet; Deficiency
Folate Deficiency
Folic Acid Deficiency
Folic Acid Overdose
Keywords: Diet
Maternal diet
Autism pregnancy
Perinatal
Folate
Folic Acid
Lead sponsor: Walden University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 239
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This survey asks mothers to provide information about their experiences with diet and supplementation during pregnancy.

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.

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

Primary outcomes:
measure: Association between maternal folate intake during pregnancy and the occurrence of ASD in the offspring via questionnaire.
timeFrame: 42 weeks gestation
Secondary outcomes:
measure: Association between mother's co-morbidities and the occurrence of ASD in offspring via questionnaire.
timeFrame: 42 weeks gestation
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Walden University
state: Minnesota
Study officials:
affiliation: Student
name: Michael M Haniff
role: PRINCIPAL_INVESTIGATOR
References: