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

Tracking Information

First Received Date ^ICMJE

February 21, 2006

Last Updated Date

December 16, 2009

Start Date ^ICMJE

October 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Score on a psychomotor development scale after a 6 and 12 months treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00294593 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Down Syndrome

Intervention ^ICMJE

Drug: folinic acid

Study Arm (s)

Not Provided

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.
Lejeune J. [Pathogenesis of mental impairment in trisomy 21] Ann Genet. 1991;34(2):55-64. Review. French.
Blehaut H, Mircher C, Ravel A, Conte M, de Portzamparc V, Poret G, de Kermadec FH, Rethore MO, Sturtz FG. Effect of leucovorin (folinic acid) on the developmental quotient of children with Down's syndrome (trisomy 21) and influence of thyroid status. PLoS One. 2010 Jan 11;5(1):e8394.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

December 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

3 Months to 30 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00294593

Other Study ID Numbers ^ICMJE

IJL-FA-TH01

Has Data Monitoring Committee

Not Provided

Responsible Party

Franck Sturtz, Institut Jerome Lejeune

Study Sponsor ^ICMJE

Institut Jerome Lejeune

Collaborators ^ICMJE

Fondation Jérôme Lejeune

Investigators ^ICMJE

Study Director:	Henri Blehaut, M.D.	Institut Jerome Lejeune
Principal Investigator:	Clotilde Mircher, MD	Institut Jerome Lejeune

Information Provided By

Institut Jerome Lejeune

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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