Trisiomy 21 (Down Syndrome) Clinical Trial
| NCT number | NCT00378456 |
| Other study ID # | 98CH11 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | September 19, 2006 |
| Last updated | September 19, 2006 |
| Verified date | September 2006 |
| Source | Institute of Child Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Research Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | N/A to 7 Months |
| Eligibility |
Inclusion Criteria: - Under 7 months of age - Trisomy 21 - Live in recruitment Area-i.e. London inside M25, in West Midlands or SW England. - One parent speaks English Exclusion Criteria: - No life threatening cardiac disease |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Institute of Child Health | Birmingham | |
| United Kingdom | Peninsular Medical School | Exeter | |
| United Kingdom | Institute of Child Health, London | London |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Child Health |
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