AutismNCT05453708
Maternal Risk Factors for Autism Spectrum Disorders: A Case-Control Approach
An observational study of Autism and Autism Spectrum Disorder, run by Walden University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder, Autistic Disorder
- What is being tested?
- Survey
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2022to 22 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This survey asks mothers to provide information about their experiences with diet and supplementation during pregnancy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Autism, Autism Spectrum Disorder, Autistic Disorder, Pregnancy Related, Diet, Healthy, Diet; Deficiency
- Being tested
- Survey
- Keywords
- Diet, Maternal diet, Autism pregnancy, Perinatal, Folate, Folic Acid
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Malnutrition, Folic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
One 15-20-minute survey
| Study group | Role | What they receive |
|---|---|---|
| Autism Risk | Survey for mothers 18 years or older with a child aged 3-12 years who has an official ASD diagnosis from a clinician. Receives: Other: Survey | |
| Controls | Survey for 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. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 weeks gestation
Secondary outcomes (1)
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.
Measured: 42 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start16 Jun 2022
- Primary completion22 Jan 2023
- Study completion22 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walden University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Haniff, Walden University
- Investigators
- Michael M Haniff, Principal investigator, Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453708
- Sponsor's protocol ID
- 06-16-22-0412467
- Status last verified
- Mar 2023
- First submitted
- 6 Jul 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Risk Factors for Autism Spectrum Disorders: A Case-Control Approach
- ClinicalTrials.gov ID
- NCT05453708
- Acronym / sponsor ID
- 06-16-22-0412467
- Conditions
- Autism, Autism Spectrum Disorder, Autistic Disorder, Pregnancy Related, Diet, Healthy, Diet; Deficiency
- Keywords
- Diet, Maternal diet, Autism pregnancy, Perinatal, Folate, Folic Acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Walden UniversityUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 22 Jan 2023 (actual)
- Study completion
- 22 Jan 2023 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Risk | – | Other: SurveySurvey for mothers 18 years or older with a child aged 3-12 years who has an official ASD diagnosis from a clinician. |
| Controls | – | Other: SurveySurvey for 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This survey asks mothers to provide information about their experiences with diet and supplementation during pregnancy.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyOne 15-20-minute survey | Other | Autism Risk, Controls |
Primary outcome
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.
1 secondary outcome
Association between mother's co-morbidities and the occurrence of ASD in offspring via questionnaire.
Time frame: 42 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Autism
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael M Haniff principal investigator
Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Autism Spectrum Disorder, run by Walden University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between maternal folate intake during pregnancy and the occurrence of ASD in the offspring via questionnaire. (time frame: 42 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.