Vitamins and Minerals for Children With Downs Syndrome

Institute of Child Health

Status: Completed

Conditions: Trisiomy 21 (Down Syndrome)

Treatments: Drug: Vitamins A,C,E Selenium and Zinc and Folinic acid.; Drug: Placebo; Drug: Folinic acid; Drug: Antioxidants- (Vitamins A,C,E Selenium and Zinc)

Study type: Interventional

Funder types: Other

Identifiers

NCT00378456

98CH11

Details and patient eligibility

About

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.

Sex: All

Ages: Under 7 months old

Volunteers: No Healthy Volunteers

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