Overview

Vitamins and Minerals for Children With Downs Syndrome

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Details
Lead Sponsor:
Institute of Child Health
Treatments:
Antioxidants
Folic Acid
Leucovorin
Levoleucovorin
Retinol palmitate
Selenium
Vitamin A
Vitamins
Zinc
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