Dataset Information

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

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.

SUBMITTER: Ellis JM

PROVIDER: S-EPMC2267988 | biostudies-literature | 2008 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Ellis Jill M JM Tan Hooi Kuan HK Gilbert Ruth E RE Muller David P R DP Henley William W Moy Robert R Pumphrey Rachel R Ani Cornelius C Davies Sarah S Edwards Vanessa V Green Heather H Salt Alison A Logan Stuart S

BMJ (Clinical research ed.) 20080221 7644

<h4>Objectives</h4>To assess whether supplementation with antioxidants, folinic acid, or both improves the psychomotor and language development of children with Down's syndrome.<h4>Design</h4>Randomised controlled trial with two by two factorial design.<h4>Setting</h4>Children living in the Midlands, Greater London, and the south west of England.<h4>Participants</h4>156 infants aged under 7 months with trisomy 21.<h4>Intervention</h4>Daily oral supplementation with antioxidants (selenium 10 mug, ...[more]

PMID: 18296460

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Dataset Information

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

Objectives

Design

Setting

Participants

Intervention

Main outcome measures

Results

Conclusions

Trial registration

Publications

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

Similar Datasets

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