Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-27 @ 9:53 AM
Study NCT ID:
NCT01921192
Status:
UNKNOWN
Last Update Posted:
2013-08-13
First Post:
2013-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D025101', 'term': 'Vitamin B 6'}, {'id': 'D014805', 'term': 'Vitamin B 12'}], 'ancestors': [{'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': 'D010847', 'term': 'Picolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'lastUpdateSubmitDate': '2013-08-08', 'studyFirstSubmitDate': '2013-08-08', 'studyFirstSubmitQcDate': '2013-08-08', 'lastUpdatePostDateStruct': {'date': '2013-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'vitamin B6', 'timeFrame': '12 months'}, {'measure': 'vitamin B12', 'timeFrame': '12 months'}], 'primaryOutcomes': [{'measure': 'homocysteine', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'folic acid', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['Non Proliferative Diabetic Retinopathy', 'Proliferative Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'Homocysteine, a well-known inducer of vascular endothelial cell damage has been associated with extracellular matrix changes. Many studies demonstrated that high levels of this aminoacid in diabetic patients increases significantly the risk of the development of this pathology. This study has been undertaken to investigate the role of homocysteine and its cofactors (folic acid, vitamin B6 and B12) during the progression of the diabetic retinopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetic patients with proliferative and non proliferative retinopathy\n\nExclusion Criteria:\n\n* Patients with chronic liver disease Patients with kidney disease.'}, 'identificationModule': {'nctId': 'NCT01921192', 'briefTitle': 'Effect of Folic Acid, Vitamin B6 and Vitamin B12 in Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'orgStudyIdInfo': {'id': '1/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Folic Acid, vit B6 and B12', 'interventionNames': ['Drug: Folic Acid, vit B6 and B12']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Folic Acid, vit B6 and B12', 'type': 'DRUG', 'armGroupLabels': ['Folic Acid, vit B6 and B12']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95125', 'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'University of Catania, Cannizzaro Hospital', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'centralContacts': [{'name': 'Mariano Malaguarnera, A.P.', 'role': 'CONTACT', 'email': 'malaguar@unict.it', 'phone': '+39(0)957262008'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mariano Malaguarnera', 'investigatorAffiliation': 'University of Catania'}}}}