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

This study has been completed.
Fondation Jérôme Lejeune
Information provided by:
Institut Jerome Lejeune Identifier:
First received: February 21, 2006
Last updated: December 16, 2009
Last verified: December 2009
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 Intervention Phase
Down Syndrome Drug: folinic acid Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Institut Jerome Lejeune:

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

Estimated Enrollment: 120
Study Start Date: October 2000
Estimated Study Completion Date: December 2003

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00294593

Institut Jerome Lejeune
Paris, France, 75015
Sponsors and Collaborators
Institut Jerome Lejeune
Fondation Jérôme Lejeune
Study Director: Henri Blehaut, M.D. Institut Jerome Lejeune
Principal Investigator: Clotilde Mircher, MD Institut Jerome Lejeune
  More Information

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 Identifier (NCT Number):
Responsible Party: Franck Sturtz, Institut Jerome Lejeune Identifier: NCT00294593     History of Changes
Other Study ID Numbers: IJL-FA-TH01
Study First Received: February 21, 2006
Last Updated: December 16, 2009

Keywords provided by Institut Jerome Lejeune:
Down syndrome
folinic acid therapy
cognitive functions

Additional relevant MeSH terms:
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
Growth Substances
Hematinics processed this record on September 19, 2017