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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05453708
• Other study ID #: 06-16-22-0412467
• Status: Completed
• Start date: June 16, 2022
• Est. completion date: January 22, 2023

Study information

• Verified date: March 2023
• Source: Walden University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: January 22, 2023
• Est. primary completion date: January 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Diet, Healthy
• Diet; Deficiency
• Disease
• Folate Deficiency
• Folic Acid Deficiency
• Malnutrition
• Pregnancy Related

Intervention

Other:
• Survey
One 15-20-minute survey

Locations

Country	Name	City	State
United States	Walden University	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Walden University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between maternal folate intake during pregnancy and the occurrence of ASD in the offspring via questionnaire.	Number of participants with a child diagnosed with ASD who used multivitamins or folate/folic acid supplements during pregnancy as assessed by the questionnaire.	42 weeks gestation
Secondary	Association between mother's co-morbidities and the occurrence of ASD in offspring via questionnaire.	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.	42 weeks gestation

External Links

•   Please visit http://www.autismrisksurvey.com to participate