NCT00378456
Completed
Not Applicable
Vitamins and Minerals for Children With Downs Syndrome
ConditionsTrisiomy 21 (Down Syndrome)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trisiomy 21 (Down Syndrome)
- Sponsor
- Institute of Child Health
- Locations
- 3
- Status
- Completed
- Last Updated
- 19 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
Study Sites (3)
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