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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Institut Jerome Lejeune

Current Primary Outcome: Score on a psychomotor development scale after a 6 and 12 months treatment

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Institut Jerome Lejeune

Dates:
Date Received: February 21, 2006
Date Started: October 2000
Date Completion: December 2003
Last Updated: December 16, 2009
Last Verified: December 2009