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Vitamins and Minerals for Children With Downs Syndrome

NCT00378456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2006-09-20

No results posted yet for this study

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.

Conditions

  • Trisiomy 21 (Down Syndrome)

Interventions

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

Sponsors & Collaborators

  • Institute of Child Health

    lead OTHER

Principal Investigators

  • Stuart Logan · Peninsular Medical School, Exeter

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
7 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00378456 on ClinicalTrials.gov