Trial | NCT00294593  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    leucovorin ...

  • Study Participants

    120
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.
Study Started
Oct 31
2000
Study Completion
Dec 31
2003
Last Update
Dec 17
2009
Estimate

Drug folinic acid

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
No Results Posted