Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial

doi:10.1136/bmj.39465.544028.AE

BMJ 2008;336:594-597 (15 March), doi:10.1136/bmj.39465.544028.AE (published 21 February 2008)

Research

Supplementation with antioxidants and folinic acid for children with Down’s syndrome: randomised controlled trial

Jill M Ellis, training fellow in evidence-based community child health¹, Hooi Kuan Tan, data manager¹, Ruth E Gilbert, professor of clinical epidemiology¹, David P R Muller, professor of biochemistry², William Henley, senior lecturer in statistics³, Robert Moy, senior lecturer in community child health⁴, Rachel Pumphrey, research assistant⁴, Cornelius Ani, specialist registrar and honorary lecturer⁵, Sarah Davies, research assistant¹, Vanessa Edwards, research fellow⁶, Heather Green, research assistant², Alison Salt, consultant developmental paediatrician¹, Stuart Logan, professor of paediatric epidemiology⁶

¹ Centre for Evidence-based Child Health, Centre for Paediatric Epidemiology and Biostatistics, UCL Institute of Child Health, London WC1N 1EH, ² Biochemistry Unit, UCL Institute of Child Health, ³ School of Mathematics and Statistics University of Plymouth, Plymouth PL4 8AA, ⁴ Institute of Child Health, University of Birmingham, Birmingham B4 6NH, ⁵ Academic Unit of Child and Adolescent Psychiatry, Imperial College, St Mary’s Campus, London W2 1PG, ⁶ Peninsula Medical School, St Luke’s Campus, Exeter EX1 2LU

Correspondence to: S Logan stuart.logan{at}pms.ac.uk

Objectives To assess whether supplementation with antioxidants,folinic acid, or both improves the psychomotor and languagedevelopment of children with Down’s syndrome.

Design Randomised controlled trial with two by two factorialdesign.

Setting Children living in the Midlands, Greater London, andthe south west of England.

Participants 156 infants aged under 7 months with trisomy 21.

Intervention Daily oral supplementation with antioxidants (selenium10 µg, zinc 5 mg, vitamin A 0.9 mg, vitamin E 100 mg,and vitamin C 50 mg), folinic acid (0.1 mg), antioxidants andfolinic acid combined, or placebo.

Main outcome measures Griffiths developmental quotient and anadapted MacArthur communicative development inventory 18 monthsafter starting supplementation; biochemical markers in bloodand urine at age 12 months.

Results Children randomised to antioxidant supplements attainedsimilar developmental outcomes to those without antioxidants(mean Griffiths developmental quotient 57.3 v 56.1; adjustedmean difference 1.2 points, 95% confidence interval –2.2to 4.6). Comparison of children randomised to folinic acid supplementsor no folinic acid also showed no significant differences inGriffiths developmental quotient (mean 57.6 v 55.9; adjustedmean difference 1.7, –1.7 to 5.1). No between group differenceswere seen in the mean numbers of words said or signed: for antioxidantsversus none the ratio of means was 0.85 (95% confidence interval0.6 to 1.2), and for folinic acid versus none it was 1.24 (0.87to 1.77). No significant differences were found between anyof the groups in the biochemical outcomes measured. Adjustmentfor potential confounders did not appreciably change the results.

Conclusions This study provides no evidence to support the useof antioxidant or folinic acid supplements in children withDown’s syndrome.

Trial registration Clinical trials NCT00378456 [ClinicalTrials.gov] .

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