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

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

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.

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