Vitamins and Minerals for Children With Downs Syndrome
Summary
The trial aimed to examine the effects of supplementation with antioxidants and folinic acid on the health, growth and psychomotor development of children with Down syndrome. 156 children with Trisomy 21, less than 7 months of age were recruited and randomised into four groups to receive antioxidants, folinic acid, a combination of antioxidants and folinic acid or a placebo. Blinded outcome assessment was carried out 18 months later.Blood and urine samples were also taken around 12 months of age to examine metabolic effects of supplementation.
Timeline
- Start
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- Primary completion
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- Completion
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Outcome
Missed primary endpoint
paper Children randomised to antioxidant supplements attained similar developmental outcomes to those without antioxidants PMID 18296460 ↗
paper Comparison of children randomised to folinic acid supplements or no folinic acid also showed no significant differences in Griffiths developmental quotient PMID 18296460 ↗
paper This study provides no evidence to support the use of antioxidant or folinic acid supplements in children with Down's syndrome. PMID 18296460 ↗
Publications
- Ellis JM, Tan HK, Gilbert RE, Muller DP, Henley W, Moy R, Pumphrey R, Ani C, Davies S, Edwards V, Green H, Salt A, Logan S. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21.
- Ellis J, Logan S, Pumphrey R, Tan HK, Henley W, Edwards V, Moy R, Gilbert R. Inequalities in provision of the Disability Living Allowance for Down syndrome. Arch Dis Child. 2008 Jan;93(1):14-6. doi: 10.1136/adc.2006.112839. Epub 2007 Mar 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leucovorin | Small molecule | 0.1 mg | Oral |
| Subject | Selenium | Other / unclassified | 10 ug | Oral |
| Subject | Vitamin A | Unknown | 0.9 mg | Oral |
| Subject | Vitamin C | Other / unclassified | 50 mg | Oral |
| Subject | Vitamin E | Other / unclassified | 100 mg | Oral |
| Subject | Zinc Sulfate | Unknown | 5 mg | Oral |