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

• Sponsor: Institut Jerome Lejeune (Other)
• Overall Status: Completed
• CT.gov ID: NCT00294593
• Collaborator: Fondation Jérôme Lejeune (Other)
• Enrollment: 120
• Location: 1
• Duration (Months): 38
• Patients Per Site Per Month: 3.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome	Drug: folinic acid	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2000
• Study Completion Date: Dec 1, 2003

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 30 Months
• Sexes Eligible for Study: 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:

• history of leukemia

• West syndrome or non-stable epilepsy

• non-stable thyroxin treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Jerome Lejeune	Paris		France	75015

Sponsors and Collaborators

• Institut Jerome Lejeune
• Fondation Jérôme Lejeune

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.

• ClinicalTrials.gov Identifier: NCT00294593
• Other Study ID Numbers: IJL-FA-TH01
• First Posted: Feb 22, 2006
• Last Update Posted: Dec 17, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: Down syndrome; folinic acid therapy; cognitive functions
• Additional relevant MeSH terms: Down Syndrome; Syndrome; Leucovorin; Folic Acid; Levoleucovorin

Study Results

No Results Posted as of Dec 17, 2009