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NCT00294593 Clinical Trial

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

Down Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00294593
Other study ID # IJL-FA-TH01
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received February 21, 2006
Last updated December 16, 2009
Start date October 2000
Est. completion date December 2003

Study information
Verified date December 2009
Source Institut Jerome Lejeune
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date December 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 30 Months
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• folinic acid

Locations
Country Name City State
France Institut Jerome Lejeune Paris

Sponsors (2)
Lead Sponsor Collaborator
Institut Jerome Lejeune Fondation Jérôme Lejeune

Country where clinical trial is conducted

France, 

References & Publications (2)

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.

Lejeune J. [Pathogenesis of mental impairment in trisomy 21]. Ann Genet. 1991;34(2):55-64. Review. French. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Score on a psychomotor development scale after a 6 and 12 months treatment
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