A randomised controlled trial of the effects of antioxidant and folinic acid supplementation on the mental development, growth and health of children with Down's Syndrome
| DEC-NET Serial number GB431 | |
| Published online | 27/06/2005 11.42.00 |
| Last updated | 01/08/2005 12.36.41 |
| Other protocol ID number | N0012089053 |
| This trial has been approved by an ethics committee | |
| Current trial status | Complete(closed to recruitment of participants: follow-up complete) |
| Major Disease (ICD9 class) | DOWN'S SYNDROME |
| Experimental drug | |
| Folinic acid | |
| Antioxidants | |
| Gender | Both |
| Age (range) | 0-24 months |
Eligibility criteria | |
| Inclusion criteria | |
| Trisomy 21 | |
| Exclusion criteria | |
| 1. Refusals 2. Translocation and mosaic forms of DS 3. Children with severe inoperable congenital cardiac defects 4. Babies with other severe congenital malformations that necessitate long term perental nutrition or gastrostomy feeding 5. Babies very ill for other reasons 6. Any other condition likely to affect mental development 7. Children of parents who do not speak English | |
Trial design/methodology | |
| Phase | 3 |
| Kind of study | Efficacy |
| Design | Controlled Randomised Blinded Double blind |
| Purpose of study | |
| To assess the effect of administering high (but safe) doses of antioxidants to infants (0-24 months) with Down's syndrome on morbidity, growth, mental and psychomotor development, and behaviour | |
| Primary outcomes | |
| Positive effects on mental development, growth and health | |
| Summary of study design, objectives, and ongoing research findings | |
| Randomised, placebo-controlled trial aiming to evaluate the effects of antioxidant vitamin and folinic acid supplementation for young children with Down's syndrome. Final outcome measures of health, growth and cognitive development after 18-months on trial supplements will be compared between groups. | |
| Principal investigator | |
| Name | Dr DPR Muller |
| Institution | Great Ormond Street Hospital |
| Postal address | Biochemistry, Endcrinology and Metabolism, Great Ormond Street Hospital, Great Ormond Street, WC1N 3JN |
| City | London |
| Country | UNITED KINGDOM |
| Phone | 020 7905 2631 |
| Fax | 020 74 61 91 |
| D.Muller@ich.ucl.ac.uk | |
| Sponsor name |
| The Down's Syndrome Association (Charity) |
| The Jerome Lejeune Foundation (Charity) |
| The Down's Syndrome Research Foundation (Charity) |
| Participating centres |
| Great Ormond Street (London) |
| Institute of Child Health (Birmingham and the West Midlands) |
| Institute of Child Health (London) |
| Peninsula Medical School (Exeter and the South West) |
| ISRCTN | EudraCT |
