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

Institut Jerome Lejeune120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Down Syndrome

Interventions

folinic acidDRUG

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 30 Months

Medical Language ↔ Plain English

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

Locations (1)

Institut Jerome Lejeune

Paris, France

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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