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Clinical Trials/NCT02674022
NCT02674022
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country59 target enrollmentJanuary 20, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Mayo Clinic
Enrollment
59
Locations
1
Primary Endpoint
Homocysteine level
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 20, 2016
End Date
April 5, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bryan K. Woodruff

Assistant Professor of Neurology

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (1)

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