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Vitamins and Minerals for Children With Downs Syndrome

NCT ID: NCT00378456

Last Updated: 2006-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Trisiomy 21 (Down Syndrome)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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

Intervention Type DRUG

Folinic acid

Intervention Type DRUG

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Child Health

OTHER

Sponsor Role lead

Principal Investigators

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Stuart Logan

Role: PRINCIPAL_INVESTIGATOR

Peninsular Medical School, Exeter

Locations

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Institute of Child Health

Birmingham, , United Kingdom

Site Status

Peninsular Medical School

Exeter, , United Kingdom

Site Status

Institute of Child Health, London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 18296460 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17344250 (View on PubMed)

Other Identifiers

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98CH11

Identifier Type: -

Identifier Source: org_study_id