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Leucovorin Study for Autism

Posted Feb 01 2013 12:00am

Lee SIlsby Managing Editor's Note:  We are proud to share with you that  Lee Silsby Compounding Pharmacy in Cleveland, Ohio, is supplying the Leucovorin for this study below. Alan Israel, lead pharmacist, has been a leader in our community to ensure safe, effective biomedical treatments for our children. On a personal note, Lee Silsby was the first pharmacy I ever used for girls' back in 2001 and I've never forgotten their customer care and attention.  Thank you, Alan and the staff at LS.  KRS

A Folinic acid intervention for ASD

Dr. Richard Frye is conducting an exciting study on the impact of a daily treatment of folinic acid on ASD-related symptoms. The hypothesis is that an folinic acid will improve folate metabolism in the brain, oxidative stress and mitochondrial function in children with autism, resulting in specific health improvements for patients with autism, a discovery that would be very welcome by the autism community.

Lee Silsby Compounding Pharmacy has been selected as the sole supplier of Leucovorin (folinic acid) for the study. Alan Israel, R. Ph., the lead pharmacist at Lee Silsby, stated that the biomedical community can benefit greatly from more research and that he is willing to help out as much as possible. To his credit, Lee Silsby Compounding Pharmacy has agreed to provide folinic acid for both the double-blind placebo-controlled portion of the trial as well as the open-label portion of the trial at no cost to the patients in the trial.

Dr. Frye’s current proposal can potentially provide strong evidence for a folinic acid intervention and will provide insight into the subgroups of children with ASD who would benefit from folinic acid.  The primary goal is to improve language for those with ASD (which is measured by the receptive and expressive CELF language index). Preliminary studies have suggested that a folinic acid intervention is associated with receptive and expressive language improvements. For example, in a case-series of 44 children with ASD and the folate receptor alpha autoantibody, treatment with high-dose folinic acid (2 mg/kg/day divided twice a day; maximum dose 50mg / day) improved communication, attention, and stereotypical behavior in many children with ASD.

Folate is an essential B vitamin required for normal neurodevelopment.  Defects in folate metabolism can cause secondary physiological abnormalities, some of which have been associated with ASD.  In this study, Dr. Frye and his team aim to study several physiological mechanisms associated with folate abnormalities in children with ASD: the folate receptor alpha autoantibody that reduce folate transport across the blood-brain barrier, low glutathione redox status, mitochondrial dysfunction and genetic polymorphisms. Most importantly, ASD patients with these physiological mechanisms have shown improvement in ASD symptoms with a folinic acid intervention.

The goal of the study is to extend these preliminary findings by documenting response to a folinic acid intervention in a double-blind placebo-controlled manner and test whether the folinic receptor alpha autoantibody titers, glutathione status, mitochondrial function and genetic polymorphisms predict response to a folinic acid intervention. If any of these measures of physiological dysfunction predict response to the intervention, such titers could provide a biomarker to identify a subset of children with ASD that may benefit from a folinic acid intervention and may even predict the development of ASD symptoms in high risk siblings during the presymptomatic period.

Using these biomarkers, it may be possible that children with ASD who optimally respond to the folinic acid intervention can be readily identified early after diagnosis or even during the pre-symptomatic period.

The study is being conducted at the Arkansas Children’s Hospital and it has S. Jill James, PhD and Stepan Melnky, MD, PhD as co-investigators and in collaboration with Dr Edward Quadros, Ph.D. at SUNY Downstate in Brooklyn, NY.

Lee Silsby Compounding Pharmacy specializes in autism and is determined to make a difference in the lives of patients with autism. Please contact for more information.



Lee Silsby logo 09 The treatment category is sponsored by Lee Silsby , the leader in quality compounded medications for autism.

Posted by Age of Autism at February 12, 2013 at 5:43 AM in Sponsor News , Treatment , Treatment Permalink

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