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

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Jerome Lejeune
• Collaborator: Fondation Jérôme Lejeune
• Treatments: Folic Acid; Leucovorin; Levoleucovorin

Criteria

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