Evaluation of Cu, Zn and Se levels in the North American Autism Spectrum Disorder Population

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-002689
    Sponsor Protocol Number: 17-002689

About this study

The purpose of this study is to confirm a correlation between metal ion dyshomeostasis (low Zn levels, abnormal Zn/Cu ratio, or low Selenium levels) in a North American population and the diagnosis of ASD using gold standard diagnostic instruments.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • 24-47 months-old males and females                             
  • Diagnosis of Autism Spectrum Disorder with or without language impairment and
  • Diagnosis of Autism Spectrum Disorder with or without language impairment and intellectual disability as determined by a clinical Dana Program Evaluation        

Heathy Controls

  • Inclusion
    • 24-47 months-old Males and females
  • Exclusion
    • NICU follow up clinic
    • Patients with concerns of developmental delay
    • Patients with seizures
    • Zn supplements taken in the last 4 months
    • MCHAT screen score of 4 or higher 
    • ASQ score below 35 in any domain

Exclusion Criteria:

  • Bleeding or clotting disorder
  • Zn supplements taken in the last 4 months

 

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sunil Mehta, M.D., Ph.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Julia Byrne

(507)538-0893

Byrne.Julia@mayo.edu

.
CLS-20320968

Mayo Clinic Footer