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

NCT ID: NCT00294593

Last Updated: 2009-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2003-12-31

Brief Summary

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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

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Conditions

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Down Syndrome

Keywords

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Down syndrome folinic acid therapy cognitive functions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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folinic acid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

30 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Jérôme Lejeune

OTHER

Sponsor Role collaborator

Institut Jerome Lejeune

OTHER

Sponsor Role lead

Responsible Party

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Institut Jerome Lejeune

Principal Investigators

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Henri Blehaut, M.D.

Role: STUDY_DIRECTOR

Institut Jerome Lejeune

Clotilde Mircher, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Jerome Lejeune

Locations

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Institut Jerome Lejeune

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND

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

Reference Type BACKGROUND
PMID: 1836122 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20084109 (View on PubMed)

Other Identifiers

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IJL-FA-TH01

Identifier Type: -

Identifier Source: org_study_id