To: Mothers of Children Ages 2-5 years
Re: Invitation to participate in a research study on
Screening for Maternal Risk Factors for Autism
We are inviting participation in a research study to screen for maternal risk factors for having a child with autism. The study is open to women who have a child with autism or without autism ages 2-5 years. This study has been approved by the Human Subjects Institutional Review Board at Arizona State University and at Mayo Clinic.
The screening involves one visit for an early morning (fasting) blood and urine collection (about 5 minutes), a stool collection kit at home (takes about 5 minutes) and filling out a medical history, dietary history, and medical symptoms form (about 20 minutes). Mothers of children with autism will also be interviewed by phone for about 90 minutes to verify their child’s diagnosis using the Autism Diagnostic Interview-Revised (ADI-R), a gold standard for diagnosing autism.
The blood test will check for abnormal homocysteine and hundreds of other metabolites. Based on previous studies, we estimate that abnormal test results will occur in about 5% of mothers of typical children, and in about 25-50% of mothers of children with autism. Elevated homocysteine is a risk factor for coronary artery disease, correlating with risk of blood clots, heart attacks, and strokes, and probably also a risk factor for having a child with autism. The standard therapy for elevated homocysteine is a vitamin supplement containing folic acid and vitamin B12.
If test results are abnormal, you will be invited to an individual meeting with Dr. Bryan Woodruff at Mayo Clinic. He will explain your test results, and discuss your possible involvement in a research study. The study would include:
1) 4 weeks of a standard vitamin/mineral supplement (similar to commonly used prenatal supplements)
2) Repeating the blood and urine test.
3) If test results are still abnormal, there will be 4 weeks of an improved vitamin/mineral supplement, specially designed for treating elevated homocysteine.
Eligibility Criteria:
1) Mother of a young child (ages 2-5 years).
2) Not currently pregnant or planning to become pregnant in the next 6 months
3) No usage of vitamin/mineral supplements currently or in the last 2 months
If you meet the above criteria, we are inviting your voluntary participation in our study.
If you choose not to participate or to withdraw from the study at any time, there will be no penalty. The results of the research study may be published, but your name will not be used, and we will maintain confidentiality of your test results.
Benefits
Each participant will receive a copy of their laboratory tests. There are no other known benefits for participation in this study.
Cost/Payments:
There is no cost to participate in this study.
All participants will receive a $50 gift certificate for participating in the study.
Possible Side-Effects/Safety Issues:
1) Blood Draw: There is a risk of bruising (rare) and a risk of anxiety about the blood draw (common). We will reduce this risk by using an experienced phlebotomist and encouraging you to drink plenty of water before the blood draw.
2) Vitamin/mineral supplements: The supplements may cause stomach upset/nausea in rare cases. This risk is minimized by requiring that they be taken with food. It is possible that other rare side-effects may occur, but this risk will be minimized by slowly increasing the dose over 1 week, and reducing the dose or stopping it if any adverse effects occur. The dosage of the vitamins and minerals are within the Tolerable Upper Limits set by the government, such that no side-effects are expected at those dosages.
Thank you for your interest in the study, which will help test an improved vitamin/mineral supplement to reduce elevated homocysteine.
If you have any questions concerning the research study, please contact the study director Prof. James Adams at
jim.adams@asu.edu (preferred) or call him at (480) 965-3316. Thank you very much for your time.
Sincerely,
James B. Adams, Ph.D.
President’s Professor, Fulton Schools of Engineering
Graduate faculty in Chemistry and Biochemistry
Director, Autism/Asperger’s Research Program
Arizona State University
Bryan Woodruff, MD
Neurologist
Mayo Clinic