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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy, Autistic Disorder, Folic Acid Deficiency

Intervention / Treatment
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* Dietary Supplement: Prenatal supplement


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mothers of Children with ASD<br>Initial treatment with standard prenatal supplement in mothers with abnormal homocysteine levels; additional treatment with optimized prenatal supplement in mothers not responding adequately to initial treatment. | Dietary Supplement: Prenatal supplement<br>* Treatment with a standard and optimized prenatal supplement, dependent on laboratory evaluations of participants.<br>|
| Active Comparator: Mothers of Typically Developing Children<br>Initial treatment with standard prenatal supplement in mothers with abnormal homocysteine levels; additional treatment with optimized prenatal supplement in mothers not responding adequately to initial treatment. | Dietary Supplement: Prenatal supplement<br>* Treatment with a standard and optimized prenatal supplement, dependent on laboratory evaluations of participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homocysteine level | Serial homocysteine level determination to assess response to supplementation with standard and optimized prenatal supplement in mothers exhibiting abnormal baseline homocysteine levels | 8-10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal Health, Autistic Disorder, Metabolism, Folic Acid