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Completed

NCT Number: NCT02674022

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

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

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Key information

Conditions

Pregnancy Autism Spectrum Disorder Autistic Disorder Avitaminosis Child Development Disorders, Pervasive Deficiency Diseases Folic Acid Deficiency Malnutrition Mental Disorders Neurodevelopmental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B Deficiency

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prenatal supplement

Dietary Supplement

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

Primary outcomes

  1. Homocysteine level

    Time frame: 8-10 weeks

    Serial homocysteine level determination to assess response to supplementation with standard and optimized prenatal supplement in mothers exhibiting abnormal baseline homocysteine levels

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Arizona State University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 4, 2016
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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