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

NCT ID: NCT02674022

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-20
• Study Completion Date: 2018-04-05

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.

Conditions

Pregnancy; Autistic Disorder; Folic Acid Deficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mothers of Children with ASD

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.

Group Type: ACTIVE_COMPARATOR

Prenatal supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Mothers of Typically Developing Children

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.

Group Type: ACTIVE_COMPARATOR

Prenatal supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Prenatal supplement

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Arizona State University

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Bryan K. Woodruff

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bryan Woodruff, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20468076 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 19011973 (View on PubMed)

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

15-006909

Identifier Type: -

Identifier Source: org_study_id