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Vitamins and Minerals for Children With Downs Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378456
Recruitment Status : Completed
First Posted : September 20, 2006
Last Update Posted : September 20, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Trisiomy 21 (Down Syndrome) Drug: Antioxidants- (Vitamins A,C,E Selenium and Zinc) Drug: Folinic acid Drug: Vitamins A,C,E Selenium and Zinc and Folinic acid. Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Months   (Child)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00378456

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United Kingdom
Institute of Child Health
Birmingham, United Kingdom
Peninsular Medical School
Exeter, United Kingdom
Institute of Child Health, London
London, United Kingdom
Sponsors and Collaborators
Institute of Child Health
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Principal Investigator: Stuart Logan Peninsular Medical School, Exeter

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00378456    
Other Study ID Numbers: 98CH11
First Posted: September 20, 2006    Key Record Dates
Last Update Posted: September 20, 2006
Last Verified: September 2006
Additional relevant MeSH terms:
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Down Syndrome
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Vitamin A
Folic Acid
Retinol palmitate
Growth Substances
Physiological Effects of Drugs
Trace Elements
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents