Vitamins and Minerals for Children With Downs Syndrome

This study has been completed.
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00378456
First received: September 19, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  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-Blind

Resource links provided by NLM:


Further study details as provided by Institute of Child Health:

  Eligibility

Ages Eligible for Study:   up to 7 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Institute of Child Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00378456     History of Changes
Other Study ID Numbers: 98CH11
Study First Received: September 19, 2006
Last Updated: September 19, 2006
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Down Syndrome
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Antioxidants
Selenium
Retinol palmitate
Leucovorin
Folic Acid
Vitamin A
Zinc
Vitamins
Levoleucovorin
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Micronutrients
Growth Substances
Antidotes
Hematinics
Hematologic Agents
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on August 21, 2014