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

Status:Not yet recruiting
Conditions:Neurology, Psychiatric, Women's Studies, Metabolic
Therapuetic Areas:Neurology, Pharmacology / Toxicology, Psychiatry / Psychology, Reproductive
Age Range:18 - Any
Start Date:February 2016

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

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

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.

Mothers of children with autism (age 3-5) or typically-developing children (age 3-5) who
are not currently taking prenatal vitamins/multivitamins.
We found this trial at
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
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