Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT01061320
Status:
UNKNOWN
Last Update Posted:
2010-02-03
First Post:
2010-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Alpha Tocopherol for Prevention of Contrast-induced Nephropathy in Chronic Kidney Disease (CKD) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D024502', 'term': 'alpha-Tocopherol'}, {'id': 'D024505', 'term': 'Tocopherols'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-02', 'studyFirstSubmitDate': '2010-02-02', 'studyFirstSubmitQcDate': '2010-02-02', 'lastUpdatePostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary end-point of this study is the development of CIN in placebo group compared with alpha tocopherol group.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'The secondary end-point of this study is compare urine NGAL level in CIN patients between both groups.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alpha-Tocopherol (Vitamin E)', 'Contrast induced nephropathy', 'Chronic kidney disease', 'Coronary procedures'], 'conditions': ['Contrast Induced Nephropathy']}, 'referencesModule': {'references': [{'pmid': '19845233', 'type': 'RESULT', 'citation': 'Tasanarong A, Piyayotai D, Thitiarchakul S. Protection of radiocontrast induced nephropathy by vitamin E (alpha tocopherol): a randomized controlled pilot study. J Med Assoc Thai. 2009 Oct;92(10):1273-81.'}], 'seeAlsoLinks': [{'url': 'http://www.nephrothai.org/', 'label': 'The Nephrology Society of Thailand'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the efficacy of alpha tocopherol for prevention contrast-induced nephropathy in CKD patients undergoing elective coronary procedures.', 'detailedDescription': 'Contrast-induced nephropathy (CIN) increases the likelihood of patient morbidity and mortality following coronary procedures. Contrast agents cause an acute deterioration in renal function via the generation of reactive oxygen species. Vitamin E (alpha tocopherol)was demonstrated to be anti-oxidant and anti-inflammation. The present study was designed to evaluate the administration of antioxidant vitamin E (alpha tocopherol) as a means of preventing CIN in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* serum creatinine levels \\> 1.2 mg/dL and baseline creatinine clearance levels \\< 60 mL/min (as measured in their most recent sample,drawn within 2 months prior to the beginning of the study)\n\nExclusion Criteria:\n\n* patients with acute kidney injury\n* end stage renal disease (requiring dialysis)\n* unstable renal function (as evidenced by a change in serum creatinine of \\> 0.5 mg/dL, or \\> 25%, within 14 days prior to the study)\n* allergy to any of the contrast agents\n* mechanical ventilation\n* suffered from congestive heart failure, cardiogenic shock or emergent angiography.\n* receiving NAC, mannitol, diuretics, theophylline, dopamine, vitamin E or contrast agents within 14 days before the study'}, 'identificationModule': {'nctId': 'NCT01061320', 'briefTitle': 'Efficacy of Alpha Tocopherol for Prevention of Contrast-induced Nephropathy in Chronic Kidney Disease (CKD) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'Efficacy of Alpha Tocopherol and New Biomarker (Urine NGAL) for Prevention and Early Diagnosis of Contrast-induced Nephropathy in CKD Patients Undergoing Elective Coronary Procedures', 'orgStudyIdInfo': {'id': 'MTU-I-1-53/52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'alpha tocopherol', 'interventionNames': ['Drug: alpha tocopherol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'alpha tocopherol', 'type': 'DRUG', 'otherNames': ['Bio-E-vitamin'], 'description': 'The patients were assigned to receive oral alpha tocopherol (525 IU) every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.', 'armGroupLabels': ['alpha tocopherol']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['jelly'], 'description': 'The patients were assigned to receive oral placebo every day start at five day before procedure, in the morning before procedure and 24 hr post-coronary procedure.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12121', 'city': 'Khlong Luang', 'state': 'Pathumtani', 'country': 'Thailand', 'facility': 'Adis Tasanarong', 'geoPoint': {'lat': 14.06467, 'lon': 100.64578}}], 'overallOfficials': [{'name': 'Adis Tasanarong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Thammasat University (Rangsit Campus)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Adis Tasanarong', 'oldOrganization': 'Faculty of Medicine, Thammasat University (Rangsit Campus)'}}}}