Format

Send to

Choose Destination
See comment in PubMed Commons below
BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21.

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

Author information

1
Centre for Evidence-based Child Health, Centre for Paediatric Epidemiology and Biostatistics, UCL Institute of Child Health, London WC1N 1EH.

Abstract

OBJECTIVES:

To assess whether supplementation with antioxidants, folinic acid, or both improves the psychomotor and language development of children with Down's syndrome.

DESIGN:

Randomised controlled trial with two by two factorial design.

SETTING:

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

PARTICIPANTS:

156 infants aged under 7 months with trisomy 21.

INTERVENTION:

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.

MAIN OUTCOME MEASURES:

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.

RESULTS:

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.

CONCLUSIONS:

This study provides no evidence to support the use of antioxidant or folinic acid supplements in children with Down's syndrome.

TRIAL REGISTRATION:

Clinical trials NCT00378456.

PMID:
18296460
PMCID:
PMC2267988
DOI:
10.1136/bmj.39465.544028.AE
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for HighWire Icon for PubMed Central
    Loading ...
    Support Center