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Efficacy Study of Folinic Acid to Improve Mental Development of Children With Down Syndrome

Down Syndrome Clinical Trial

Official title:
One-year Double-blind Placebo-controlled Phase 2-3 Study to Evaluate the Effect of Oral Folinic Acid Treatment (1mg/kg/d) on the Psychomotor Development of Young Down Syndrome Patients

Clinical Trial Summary

The purpose of this study is to determine whether folinic acid can improve developmental quotient of young Down syndrome patients, given that these present signs of folate deficiency which are known to cause reversible neurological, psychiatric and cognitive disorders.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00294593
Study type Interventional
Source Institut Jerome Lejeune
Contact
Status Completed
Phase Phase 2/Phase 3
Start date October 2000
Completion date December 2003
View Details
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