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Early Nutritional Intervention in Patients With Autism Spectrum Disorders

Hamad Medical Corporation · 2010
ClinicalTrials.gov · Datasets · License: Public Domain · 2010
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Nutritional supplements like vitamin B6 and magnesium have demonstrated to have beneficial effects in patients with autism spectrum disorders (ASD). The underlying theory for these effects is that specific metabolic pathways in neuronal cells, e.g. the methionine cycle, will be more balanced. Most studies have been focused on the clinical outcome with this treatment. The present proposal will examine the effects on the different intermediates of the methionine cycle (methylation and transulfuration capacity), suggested to play an important role for the pathogenesis of ASD. The design is a prospective pilot study, including 40 patients, aged 2-6 yrs, with newly diagnosed ASD. All participants will receive the supplement (vitamin B6, magnesium; Kirkman formula) and placebo in a cross over design. Metabolites in blood and urine will be measured prior to and at the end of the treatments in the different groups. The results will then provide us with information, which will link clinical outcomes with biological markers. Furthermore, the study has also the potential to shed light on the pathogenesis of ASD.
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