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Completed

NCT Number: NCT00294593

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

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

3 month–30 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Institut Jerome Lejeune

Paris, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folinic acid

Drug

Primary outcomes

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

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Sponsors and collaborators

Lead sponsor

Institut Jerome Lejeune

Other

Collaborators

  • Fondation Jérôme Lejeune

Registry information

Official study 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

Important dates

Study start
2000
Study completion
2003
First posted
Feb 22, 2006
Registry last updated
Dec 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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