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

Phase 2

Completed

• Conditions: Down Syndrome

• Registration Number: NCT00294593
• Lead Sponsor: Institut Jerome Lejeune

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 Description

Not available

Study Timeline

• Study Start: 2000-10
• Study Completion: 2003-12
• Study First Submitted: 2006-02-21
• Study First Submitted QC: 2006-02-21
• Study First Posted: 2006-02-22
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-16
• Last Update Posted: 2009-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Down syndrome without mosaicism
• age 3 to 30 months
• weight over 4 kg
• possible assessment by the revised Brunet-Lezine scale

Exclusion Criteria

• history of leukemia
• West syndrome or non-stable epilepsy
• non-stable thyroxin treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Score on a psychomotor development scale after a 6 and 12 months treatment

Trial Locations

Locations (1)

Institut Jerome Lejeune; 🇫🇷 Paris, France