Status:
COMPLETED
Efficacy Study of Folinic Acid to Improve Mental Development of Children With Down Syndrome
Lead Sponsor:
Institut Jerome Lejeune
Collaborating Sponsors:
Fondation Jérôme Lejeune
Conditions:
Down Syndrome
Eligibility:
All Genders
3-30 years
Phase:
PHASE2
PHASE3
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 t...
Eligibility Criteria
Inclusion
- Down syndrome without mosaicism
- age 3 to 30 months
- weight over 4 kg
- possible assessment by the revised Brunet-Lezine scale
Exclusion
- history of leukemia
- West syndrome or non-stable epilepsy
- non-stable thyroxin treatment
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00294593
Start Date
October 1 2000
End Date
December 1 2003
Last Update
December 17 2009
Active Locations (1)
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1
Institut Jerome Lejeune
Paris, France, 75015