Vitamins and Minerals for Children With Downs Syndrome

Not Applicable

Completed

• Conditions: Trisiomy 21 (Down Syndrome)

• Registration Number: NCT00378456
• Lead Sponsor: Institute of Child Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-09
• Study First Submitted: 2006-09-19
• Study First Submitted QC: 2006-09-19
• Last Update Submitted: 2006-09-19
• Study First Posted: 2006-09-20
• Last Update Posted: 2006-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (3)

Institute of Child Health, London; 🇬🇧 London, United Kingdom

Peninsular Medical School; 🇬🇧 Exeter, United Kingdom

Institute of Child Health; 🇬🇧 Birmingham, United Kingdom