Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT00294593
Status:
COMPLETED
Last Update Posted:
2009-12-17
First Post:
2006-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Study of Folinic Acid to Improve Mental Development of Children With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2003-12'}, 'lastUpdateSubmitDate': '2009-12-16', 'studyFirstSubmitDate': '2006-02-21', 'studyFirstSubmitQcDate': '2006-02-21', 'lastUpdatePostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on a psychomotor development scale after a 6 and 12 months treatment'}]}, 'conditionsModule': {'keywords': ['Down syndrome', 'folinic acid therapy', 'cognitive functions'], 'conditions': ['Down Syndrome']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1836122', 'type': 'BACKGROUND', 'citation': 'Lejeune J. [Pathogenesis of mental impairment in trisomy 21]. Ann Genet. 1991;34(2):55-64. French.'}, {'pmid': '20084109', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Down syndrome without mosaicism\n* age 3 to 30 months\n* weight over 4 kg\n* possible assessment by the revised Brunet-Lezine scale\n\nExclusion Criteria:\n\n* history of leukemia\n* West syndrome or non-stable epilepsy\n* non-stable thyroxin treatment'}, 'identificationModule': {'nctId': 'NCT00294593', 'briefTitle': 'Efficacy Study of Folinic Acid to Improve Mental Development of Children With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Institut Jerome Lejeune'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IJL-FA-TH01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'folinic acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Jerome Lejeune', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Henri Blehaut, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Jerome Lejeune'}, {'name': 'Clotilde Mircher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Jerome Lejeune'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Jerome Lejeune', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Jérôme Lejeune', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Franck Sturtz', 'oldOrganization': 'Institut Jerome Lejeune'}}}}