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CompletedNCT00294593Updated Dec 17, 2009

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

A Phase 2/3 interventional study of folinic acid in Down Syndrome, sponsored by Institut Jerome Lejeune. Completed at 1 site in France. Open to participants aged 3 Months to 30 Months. Per ClinicalTrials.gov, last updated 2009-12-17.

Sponsored by Institut Jerome Lejeune · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
3 Months to 30 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Down Syndrome

Keywords

  • Down syndrome
  • folinic acid therapy
  • cognitive functions
03

In context

Down Syndrome

432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.

This study's enrollment of 120 is above the median of 36 across 283 interventional studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

Institut Jerome Lejeune is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 30 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • history of leukemia
  • West syndrome or non-stable epilepsy
  • non-stable thyroxin treatment
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
120 participants

Interventions

  • Drugfolinic acid
06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • Institut Jerome Lejeune
    Paris, 75015, France
08

References and documents

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. French. PubMed 1836122 ↗
  • 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. PubMed 20084109 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00294593
Lead sponsor
Institut Jerome Lejeune
Collaborators
Fondation Jérôme Lejeune
First posted
Feb 22, 2006
Start date
Oct 2000
Completion
Dec 2003
Last update
Dec 17, 2009

Study contacts

Henri Blehaut, M.D.
study director · Institut Jerome Lejeune
Clotilde Mircher, MD
principal investigator · Institut Jerome Lejeune
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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