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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674022
• Other study ID #: 15-006909
• Status: Completed
• Phase: N/A
• Start date: January 20, 2016
• Est. completion date: April 5, 2018

Study information

• Verified date: October 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 5, 2018
• Est. primary completion date: April 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autistic Disorder
• Folic Acid Deficiency
• Pregnancy

Intervention

Dietary Supplement:
• Prenatal supplement
Treatment with a standard and optimized prenatal supplement, dependent on laboratory evaluations of participants.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Arizona State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

James SJ, Melnyk S, Jernigan S, Hubanks A, Rose S, Gaylor DW. Abnormal Transmethylation/transsulfuration Metabolism and DNA Hypomethylation Among Parents of Children with Autism. J Autism Dev Disord. 2008 Nov;38(10):1976. doi: 10.1007/s10803-008-0614-2. — View Citation

James SJ, Melnyk S, Jernigan S, Pavliv O, Trusty T, Lehman S, Seidel L, Gaylor DW, Cleves MA. A functional polymorphism in the reduced folate carrier gene and DNA hypomethylation in mothers of children with autism. Am J Med Genet B Neuropsychiatr Genet. 2010 Sep;153B(6):1209-20. doi: 10.1002/ajmg.b.31094. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials