Trials / Completed
CompletedNCT00294593
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
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 120 (planned)
- Sponsor
- Institut Jerome Lejeune · Academic / Other
- Sex
- All
- Age
- 3 Months – 30 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | folinic acid |
Timeline
- Start date
- 2000-10-01
- Completion
- 2003-12-01
- First posted
- 2006-02-22
- Last updated
- 2009-12-17
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00294593. Inclusion in this directory is not an endorsement.