levoleucovorin and Language-Disorders

We sought to determine whether high-dose folinic acid improves verbal communication in children with non-syndromic autism spectrum disorder (ASD) and language impairment in a double-blind placebo control setting. Forty-eight children (mean age 7 years 4  months; 82% male) with ASD and language impairment were randomized to receive 12 weeks of high-dose folinic acid (2 mg kg

Topics: Autism Spectrum Disorder; Autistic Disorder; Child; Child Development Disorders, Pervasive; Child, Preschool; Double-Blind Method; Female; Folate Receptor 1; Humans; Language Development Disorders; Language Disorders; Leucovorin; Male; Placebo Effect; Receptors, Peptide; Treatment Outcome; Verbal Behavior

To assess whether supplementation with antioxidants, folinic acid, or both improves the psychomotor and language development of children with Down's syndrome.. Randomised controlled trial with two by two factorial design.. Children living in the Midlands, Greater London, and the south west of England.. 156 infants aged under 7 months with trisomy 21.. Daily oral supplementation with antioxidants (selenium 10 mug, zinc 5 mg, vitamin A 0.9 mg, vitamin E 100 mg, and vitamin C 50 mg), folinic acid (0.1 mg), antioxidants and folinic acid combined, or placebo.. Griffiths developmental quotient and an adapted MacArthur communicative development inventory 18 months after starting supplementation; biochemical markers in blood and urine at age 12 months.. Children randomised to antioxidant supplements attained similar developmental outcomes to those without antioxidants (mean Griffiths developmental quotient 57.3 v 56.1; adjusted mean difference 1.2 points, 95% confidence interval -2.2 to 4.6). Comparison of children randomised to folinic acid supplements or no folinic acid also showed no significant differences in Griffiths developmental quotient (mean 57.6 v 55.9; adjusted mean difference 1.7, -1.7 to 5.1). No between group differences were seen in the mean numbers of words said or signed: for antioxidants versus none the ratio of means was 0.85 (95% confidence interval 0.6 to 1.2), and for folinic acid versus none it was 1.24 (0.87 to 1.77). No significant differences were found between any of the groups in the biochemical outcomes measured. Adjustment for potential confounders did not appreciably change the results.. This study provides no evidence to support the use of antioxidant or folinic acid supplements in children with Down's syndrome.. Clinical trials NCT00378456.

Topics: Administration, Oral; Antioxidants; Developmental Disabilities; Dietary Supplements; Down Syndrome; Glutathione Peroxidase; Humans; Infant; Language Disorders; Leucovorin; Patient Compliance; Psychomotor Disorders; Superoxide Dismutase; Treatment Outcome