Back to results

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

Primary Purpose

Down Syndrome

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

folinic acid

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Down syndrome, folinic acid therapy, cognitive functions

Eligibility Criteria

3 Months - 30 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut Jerome Lejeune

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00294593

First Posted

February 21, 2006

Last Updated

December 16, 2009

Sponsor

Institut Jerome Lejeune

Collaborators

Fondation Jérôme Lejeune

1. Study Identification

Unique Protocol Identification Number

NCT00294593

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

October 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Institut Jerome Lejeune

Collaborators

Fondation Jérôme Lejeune

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Down Syndrome

Keywords

Down syndrome, folinic acid therapy, cognitive functions

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

120 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

folinic acid

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Maximum Age & Unit of Time

30 Months

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henri Blehaut, M.D.

Organizational Affiliation

Institut Jerome Lejeune

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Clotilde Mircher, MD

Organizational Affiliation

Institut Jerome Lejeune

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Jerome Lejeune

City

Paris

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Citations:

Citation

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.

Results Reference

background

PubMed Identifier

1836122

Citation

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

Results Reference

background

PubMed Identifier

20084109

Citation

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. doi: 10.1371/journal.pone.0008394.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs