NCT00378456

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2006

Completed
Last Updated

September 20, 2006

Status Verified

September 1, 2006

First QC Date

September 19, 2006

Last Update Submit

September 19, 2006

Conditions

Trisiomy 21 (Down Syndrome)

Interventions

Antioxidants- (Vitamins A,C,E Selenium and Zinc)DRUG
Folinic acidDRUG
Vitamins A,C,E Selenium and Zinc and Folinic acid.DRUG
PlaceboDRUG

Eligibility Criteria

Age0 Years - 7 Months
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • No life threatening cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institute of Child Health

Birmingham, United Kingdom

Location

Peninsular Medical School

Exeter, United Kingdom

Location

Institute of Child Health, London

London, United Kingdom

Location

Related Publications (2)

  • Ellis JM, Tan HK, Gilbert RE, Muller DP, Henley W, Moy R, Pumphrey R, Ani C, Davies S, Edwards V, Green H, Salt A, Logan S. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21.

    PMID: 18296460DERIVED

  • Ellis J, Logan S, Pumphrey R, Tan HK, Henley W, Edwards V, Moy R, Gilbert R. Inequalities in provision of the Disability Living Allowance for Down syndrome. Arch Dis Child. 2008 Jan;93(1):14-6. doi: 10.1136/adc.2006.112839. Epub 2007 Mar 7.

    PMID: 17344250DERIVED

MeSH Terms

Conditions

Down Syndrome

Interventions

AntioxidantsZincLeucovorin

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Biological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of ChemicalsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and Coenzymes

Study Officials

  • Stuart Logan

    Peninsular Medical School, Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 20, 2006

Last Updated

September 20, 2006

Record last verified: 2006-09

Locations

GB(3)