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

Mayo Clinic

Status: Completed

Conditions: Autistic Disorder; Folic Acid Deficiency; Pregnancy

Treatments: Dietary Supplement: Prenatal supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02674022

15-006909

Details and patient eligibility

About

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

Full 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.

Enrollment: 59 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Mothers of Children with ASD

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Prenatal supplement

Mothers of Typically Developing Children

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Prenatal supplement