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

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ClinicalTrials.gov Identifier: NCT00294593
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : December 17, 2009
Fondation Jérôme Lejeune
Information provided by:
Institut Jerome Lejeune

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 to cause reversible neurological, psychiatric and cognitive disorders.

Condition or disease Intervention/treatment Phase
Down Syndrome Drug: folinic acid Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2000
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Score on a psychomotor development scale after a 6 and 12 months treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294593

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Institut Jerome Lejeune
Paris, France, 75015
Sponsors and Collaborators
Institut Jerome Lejeune
Fondation Jérôme Lejeune
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Study Director: Henri Blehaut, M.D. Institut Jerome Lejeune
Principal Investigator: Clotilde Mircher, MD Institut Jerome Lejeune
Botez MI, Botez T, Leveille J, Bielmann P, Cadotte M. Neuropsychological correlates of folic acid deficiency: facts and hypotheses. In: Botez MI, Reynolds EH, eds. Folic acid in neurology, psychiatry and internal medicine. New York, Raven Press, 1979:435-461.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Franck Sturtz, Institut Jerome Lejeune
ClinicalTrials.gov Identifier: NCT00294593    
Other Study ID Numbers: IJL-FA-TH01
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: December 17, 2009
Last Verified: December 2009
Keywords provided by Institut Jerome Lejeune:
Down syndrome
folinic acid therapy
cognitive functions
Additional relevant MeSH terms:
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Down Syndrome
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Folic Acid
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex