Study of Cholesterol Levels Under Way for Children with Autism
February 16, 2011
Investigators at Kennedy Krieger Institute affiliated with Johns Hopkins University School of Medicine, The Ohio State University's Nisonger Center, and the National Institute of Child Health and Human Development are collaborating on a two-part study of cholesterol levels in children with autism, Asperger's, or similar developmental disorder (autism spectrum disorders). Kennedy Krieger and Nisonger Center are University Centers of Excellence in Developmental Disabilities Education, Research, and Service (UCEDDs). In the first phase the investigators will test cholesterol levels in children with an autism spectrum disorder (ASD) and study the differences with low and high cholesterol. In the second phase they will examine whether a cholesterol supplement improves autism symptoms in children with an ASD and low cholesterol. Children who will be involved in this study must be diagnosed with Autistic Disorder, Asperger's Disorder, or Pervasive Developmental Disorder-Not Otherwise Specified. For those not diagnosed, a diagnostic evaluation is provided. Children in the second phase of the study, the clinical trial phase, must also have low cholesterol.
Autism Speaks has funded Drs. Elaine Tierney (KKI), L. Eugene Arnold (OSU), and Forbes D. Porter (NICHD) to investigate cholesterol levels in children with an ASD. One purpose of this study is to learn whether individuals with autism and low cholesterol differ in important ways from those with normal or high cholesterol. The second goal is to determine whether children with an ASD and low cholesterol can benefit from taking a cholesterol supplement. Researchers will evaluate children who participate in the first part of the study using psychological, psychiatric, medical, biological, behavioral, and developmental measures. Children who are found to have low cholesterol will continue on to the second part of the study in which they will receive a powdered cholesterol supplement or a placebo (a powder containing no active cholesterol supplement). A vitamin and mineral supplement will also be provided to all participants. Either the cholesterol supplement or placebo (a sugar pill) will be given over a twelve-week trial, and then all children will be given the real supplement for another twelve weeks. The ultimate goal of the study is to see if the cholesterol supplement improves autism symptoms.
Participants in this study must be between 4 and 11 years of age, inclusive; have a mental age of at least 18 months; have not taken cholesterol supplements in the last three months; not have a severe medical condition; be seizure-free for at least three months; and not be taking medications that lower cholesterol or lipid levels. Parents will not necessarily know if their children meet these criteria, so the study investigators will conduct free assessments to help determine if children qualify. If readers would like more information on this study, they can phone or email The Ohio State University study coordinator, Stacey Moone, at 614-292-3971 or [email protected], or they can visit the study website at psychmed.osu.edu
