Trisiomy 21 (Down Syndrome)
Conditions
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.
Interventions
DRUGAntioxidants- (Vitamins A,C,E Selenium and Zinc)
DRUGFolinic acid
DRUGVitamins A,C,E Selenium and Zinc and Folinic acid.
DRUGPlacebo
Sponsors
Institute of Child Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
0 Years to 7 Months
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
Countries
United Kingdom
Outcome results
None listed