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

This study has been completed.
Sponsor:
Collaborator:
Fondation Jérôme Lejeune
Information provided by:
Institut Jerome Lejeune
ClinicalTrials.gov Identifier:
NCT00294593
First received: February 21, 2006
Last updated: December 16, 2009
Last verified: December 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   3 Months to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294593

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

Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Franck Sturtz, Institut Jerome Lejeune
ClinicalTrials.gov Identifier: NCT00294593     History of Changes
Other Study ID Numbers: IJL-FA-TH01
Study First Received: February 21, 2006
Last Updated: December 16, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Down Syndrome
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Leucovorin
Folic Acid
Levoleucovorin
 Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013