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

NCT00294593 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2009-12-17

No results posted yet for this study

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

  • Down Syndrome

Interventions

DRUG

folinic acid

Sponsors & Collaborators

  • Fondation Jérôme Lejeune

    collaborator OTHER

  • Institut Jerome Lejeune

    lead OTHER

Principal Investigators

  • Henri Blehaut, M.D. · Institut Jerome Lejeune

  • Clotilde Mircher, MD · Institut Jerome Lejeune

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
30 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-10-31
Completion
2003-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00294593 on ClinicalTrials.gov