Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT00378456
Status:
COMPLETED
Last Update Posted:
2006-09-20
First Post:
2006-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamins and Minerals for Children With Downs 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': 'D000975', 'term': 'Antioxidants'}, {'id': 'D015032', 'term': 'Zinc'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'lastUpdateSubmitDate': '2006-09-19', 'studyFirstSubmitDate': '2006-09-19', 'studyFirstSubmitQcDate': '2006-09-19', 'lastUpdatePostDateStruct': {'date': '2006-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Trisiomy 21 (Down Syndrome)']}, 'referencesModule': {'references': [{'pmid': '18296460', 'type': 'DERIVED', 'citation': "Ellis JM, Tan HK, Gilbert RE, Muller DP, Henley W, Moy R, Pumphrey R, Ani C, Davies S, Edwards V, Green H, Salt A, Logan S. Supplementation with antioxidants and folinic acid for children with Down's syndrome: randomised controlled trial. BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21."}, {'pmid': '17344250', 'type': 'DERIVED', 'citation': 'Ellis J, Logan S, Pumphrey R, Tan HK, Henley W, Edwards V, Moy R, Gilbert R. Inequalities in provision of the Disability Living Allowance for Down syndrome. Arch Dis Child. 2008 Jan;93(1):14-6. doi: 10.1136/adc.2006.112839. Epub 2007 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'The trial aimed to examine the effects of supplementation with antioxidants and folinic acid on the health, growth and psychomotor development of children with Down syndrome. 156 children with Trisomy 21, less than 7 months of age were recruited and randomised into four groups to receive antioxidants, folinic acid, a combination of antioxidants and folinic acid or a placebo. Blinded outcome assessment was carried out 18 months later.Blood and urine samples were also taken around 12 months of age to examine metabolic effects of supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Months', 'minimumAge': '0 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Under 7 months of age\n* Trisomy 21\n* Live in recruitment Area-i.e. London inside M25, in West Midlands or SW England.\n* One parent speaks English\n\nExclusion Criteria:\n\n* No life threatening cardiac disease'}, 'identificationModule': {'nctId': 'NCT00378456', 'briefTitle': 'Vitamins and Minerals for Children With Downs Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Child Health'}, 'orgStudyIdInfo': {'id': '98CH11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Antioxidants- (Vitamins A,C,E Selenium and Zinc)', 'type': 'DRUG'}, {'name': 'Folinic acid', 'type': 'DRUG'}, {'name': 'Vitamins A,C,E Selenium and Zinc and Folinic acid.', 'type': 'DRUG'}, {'name': 'Placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Institute of Child Health', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Exeter', 'country': 'United Kingdom', 'facility': 'Peninsular Medical School', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Institute of Child Health, London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Stuart Logan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peninsular Medical School, Exeter'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Child Health', 'class': 'OTHER'}}}}