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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00294593

Enrollment

120

Registered

2006-02-22

Start date

2000-10-31

Completion date

2003-12-31

Last updated

2009-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome

Keywords

Down syndrome, folinic acid therapy, cognitive functions

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.

Interventions

DRUGfolinic acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

3 Months to 30 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Score on a psychomotor development scale after a 6 and 12 months treatment	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026