drugset / Trial / NCT00378456

Vitamins and Minerals for Children With Downs Syndrome

NCT00378456

RandomizedParallel-groupDouble-blind

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.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Leucovorin Small molecule 0.1 mg Oral
Subject Selenium Other / unclassified 10 ug Oral
Subject Vitamin A Unknown 0.9 mg Oral
Subject Vitamin C Other / unclassified 50 mg Oral
Subject Vitamin E Other / unclassified 100 mg Oral
Subject Zinc Sulfate Unknown 5 mg Oral

Indications