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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Institute of Child Health
Birmingham, United Kingdom
Peninsular Medical School
Exeter, United Kingdom
Institute of Child Health, London
London, United Kingdom
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