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Completed

NCT Number: NCT00378456

Vitamins and Minerals for Children With Downs Syndrome

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.

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Key information

Conditions

Trisiomy 21 (Down Syndrome) Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

0 year–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Child Health, Birmingham, United Kingdom

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antioxidants- (Vitamins A,C,E Selenium and Zinc)

Drug

Folinic acid

Drug

Vitamins A,C,E Selenium and Zinc and Folinic acid.

Drug

Placebo

Drug

Sponsors and collaborators

Lead sponsor

Institute of Child Health

Other

Registry information

Important dates

First posted
Sep 20, 2006
Registry last updated
Sep 20, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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