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Screening for Metabolic Problems in Mothers of Children With Autism and Typically Developing Children

Screening for Metabolic Problems in Women, and Possible Treatment With Vitamin/Mineral Supplement

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02674022
Enrollment
59
Registered
2016-02-04
Start date
2016-01-20
Completion date
2018-04-05
Last updated
2020-10-19

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

Conditions

Autistic Disorder, Folic Acid Deficiency, Pregnancy

Keywords

Maternal Health, Autistic Disorder, Metabolism, Folic Acid

Brief summary

The purpose of this research study is to screen for metabolic abnormalities that are maternal risk factors for having a child with autism.

Detailed description

The study will involve recruitment of 30 mothers of young children with ASD (ages 3-5 years) and 30 mothers of non-ASD children of similar age, respectively labelled ASD-moms and non-ASD-moms. In Phase 1, the levels of certain folate-related and oxidative stress biomarkers (folate, vitamin B12, vitamin E, homocysteine, methylmalonic acid, urinary isoprostanes) and MTHFR mutation analysis will be measured in all the mothers. The investigators expect that approximately 40-50% of the ASD-mothers and approximately 5-10% of the non-ASD-mothers will have abnormal homocysteine levels. In Phase 2, for those mothers with abnormal homocysteine levels, the investigators will treat them with a standard prenatal supplement for 4 weeks, and re-measure their biomarkers. The investigators expect 75-100% of the non-ASD mothers to respond, but only 25-50% of the ASD-mothers to respond. In Phase 3, for those mothers who did not respond to the standard prenatal supplement, the investigators will treat them with an optimized prenatal supplement for 4 weeks and remeasure their biomarkers. The investigators expect that 75-100% of the mothers of both groups will respond to this improved prenatal supplement.

Interventions

DIETARY_SUPPLEMENTPrenatal supplement

Treatment with a standard and optimized prenatal supplement, dependent on laboratory evaluations of participants.

Sponsors

Arizona State University
CollaboratorOTHER
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

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

Inclusion criteria

Mothers of children with autism (age 3-5) or typically-developing children (age 3-5) who are not currently taking prenatal vitamins/multivitamins.

Design outcomes

Primary

MeasureTime frameDescription
Homocysteine level8-10 weeksSerial homocysteine level determination to assess response to supplementation with standard and optimized prenatal supplement in mothers exhibiting abnormal baseline homocysteine levels

Countries

United States

Outcome results

None listed

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