Effects of vitamin B6 in children with autism: a randomized controlled trial

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2009
INTERVENTION: After 2 weeks run‐in period, pyridoxal 5'‐phosphate is given in doses of 5 mg/kg/d in the first 2 weeks. In the following 2 weeks, pyridoxal phosphate is given in doses of 10 mg/kg/d. Pyridoxal phosphate is given orally in powder or tablet form. After 2 weeks run‐in period, placebo is supplied in a powder or tablet form that is identical in appearance and taste to pyridoxal 5'‐phosphate in 4 weeks. CONDITION: Autism PRIMARY OUTCOME: Pervasive Developmental Disorders Autism Society Japan Rating Scale (PARS); Clinical Global Impressions (CGI) SECONDARY OUTCOME: Aberrant Behavior Checklist (ABC); Social Maturity Scale INCLUSION CRITERIA: 1) Meeting the ICD‐10 criteria for Childhood autism F84.0, Atypical autism F84.1, Asperger's syndrome F84.5, or Other pervasive developmental disorders F84.8 2) Having symptom of hypersensitivity to sound or plasma glutamine concentration of <420 nmol/mL
Epistemonikos ID: 7707bb44463035c8dad09b7c7204152e86216b8f
First added on: Aug 22, 2024