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

Institut Jerome Lejeune

Status and phase: Completed; Phase 3; Phase 2

Conditions: Down Syndrome

Treatments: Drug: folinic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00294593

IJL-FA-TH01

Details and patient eligibility

About

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.

Sex: All

Ages: 3 to 30 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind