Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-02-11 @ 11:13 AM
Study NCT ID:
NCT02005718
Status:
COMPLETED
Last Update Posted:
2013-12-09
First Post:
2013-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Vitamin D on Endothelial Function and Blood Biomarkers Including CD28 Null Cells in CKD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-05-25', 'releaseDate': '2016-04-19'}], 'estimatedResultsFirstSubmitDate': '2016-04-19'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2013-12-03', 'lastUpdatePostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow mediated dilation', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'CD28 null cell frequency', 'timeFrame': '16 weeks'}, {'measure': 'Blood biomarkers of endothelial function and inflammation', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['CKd Patients With Stage 3 and 4']}, 'referencesModule': {'references': [{'pmid': '24646518', 'type': 'DERIVED', 'citation': 'Chitalia N, Ismail T, Tooth L, Boa F, Hampson G, Goldsmith D, Kaski JC, Banerjee D. Impact of vitamin D supplementation on arterial vasomotion, stiffness and endothelial biomarkers in chronic kidney disease patients. PLoS One. 2014 Mar 19;9(3):e91363. doi: 10.1371/journal.pone.0091363. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'Vitamin D deficiency is common in CKD and assciated with CV complications. Endothelial dysfucntion is common in CKD and is a harbinger of atherosclerosis. The study investigated the impact of Vitamin D on endothelial fucntion and blood biomarkers in CKD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD 3-4 Age 18-80\n\nExclusion Criteria:\n\n* Recent MI, CVA, malignancy active infection active inflammation High calcium already on Viatmin D therapy'}, 'identificationModule': {'nctId': 'NCT02005718', 'briefTitle': 'Impact of Vitamin D on Endothelial Function and Blood Biomarkers Including CD28 Null Cells in CKD', 'organization': {'class': 'OTHER', 'fullName': "St George's, University of London"}, 'officialTitle': 'Impact of Cholecalciferol on Endothelial Fucntion and Blood Biomarkers in Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': '090129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin D', 'description': 'Cholecalciferol 300,000 twice', 'interventionNames': ['Drug: Cholecalciferol']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DRUG', 'armGroupLabels': ['Vitamin D']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Debasish Banerjee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Georges'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St George's, University of London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-04-19', 'type': 'RELEASE'}, {'date': '2016-05-25', 'type': 'RESET'}], 'unpostedResponsibleParty': "St George's, University of London"}}}}