Randomized Trial of Supplementation
Randomised Trial of Supplementation with Antioxidants & Folinic Acid for Children with Down Syndrome
Ellis JM, et al.
British Medical Journal: 26th Feb 2008 (Vol 336/Issue 7641)
This Research was funded by The Down’s Syndrome Association, Fondation Jérôme Lejeune, Down Syndrome Research Foundation who also helped to publicise the study to parents, Members of the Down Syndrome Medical Interest Group, particularly Jennifer Dennis who gave advice on trial design and helped to publicise the study to other doctors, Research at the Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust benefits from R&D funding received from the NHS Executive
- To assess whether supplementation with antioxidants and/or folinic acid
- Improve the psychomotor and language development of children with Down Syndrome
- Randomised controlled trial with a 2x2 factorial design
- Children living in the Midlands, Greater London and South West of England UK
- 156 infants with Trisomy 21 under 7 months of age.
- Daily oral supplementation with antioxidants (selenium 10μg, zinc 5mg, vitamin A 0.9mg, vitamin E 100mg and vitamin C 50mg), folinic acid (0.1mg), antioxidants and folinic acid combined, or placebo
Main Outcome Measures
- 18 months after starting supplementation children were assessed using the Griffiths Developmental Quotient (GQ) and an adapted Mac Arthur Communicative Development Inventory. Biochemical markers in blood and urine were also measured at 12 months of age.