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Vitamins and Minerals for Children With Downs Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00378456
First Posted: September 20, 2006
Last Update Posted: September 20, 2006
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.
Information provided by:
Institute of Child Health
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

Resource links provided by NLM:


Further study details as provided by Institute of Child Health:

  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00378456


Locations
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
Investigators
Principal Investigator: Stuart Logan Peninsular Medical School, Exeter
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00378456     History of Changes
Other Study ID Numbers: 98CH11
First Submitted: September 19, 2006
First Posted: September 20, 2006
Last Update Posted: September 20, 2006
Last Verified: September 2006

Additional relevant MeSH terms:
Syndrome
Down Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Vitamins
Vitamin A
Leucovorin
Folic Acid
Zinc
Selenium
Antioxidants
Retinol palmitate
Levoleucovorin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Antidotes


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