Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT00237718
Status:
COMPLETED
Last Update Posted:
2012-01-11
First Post:
2005-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Provision of Antioxidant Therapy in Hemodialysis (PATH) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 'D005720', 'term': 'Gamma Rays'}, {'id': 'D050986', 'term': 'YY1 Transcription Factor'}, {'id': 'D024505', 'term': 'Tocopherols'}, {'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D008063', 'term': 'Thioctic Acid'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D050981', 'term': 'Erythroid-Specific DNA-Binding Factors'}, {'id': 'D004268', 'term': 'DNA-Binding Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014157', 'term': 'Transcription Factors'}, {'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': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alp.ikizler@vanderbilt.edu', 'title': 'T. Alp Ikizler, MD', 'organization': 'Vanderbilt University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'ALA and Vitamin E', 'description': '600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months', 'otherNumAtRisk': 160, 'otherNumAffected': 91, 'seriousNumAtRisk': 160, 'seriousNumAffected': 44}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months', 'otherNumAtRisk': 165, 'otherNumAffected': 85, 'seriousNumAtRisk': 165, 'seriousNumAffected': 52}], 'otherEvents': [{'term': 'GI upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 63, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 44, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 38, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 48, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'access related', 'notes': 'Any adverse event related to the dialysis access (catheter, graft, or fistula).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 44, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 25, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pulmonary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'access related', 'notes': 'Any adverse event related to the dialysis access (catheter, graft, or fistula).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypertension/hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'electrolyte disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'lesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'F2-isoprostane (F2-iso)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALA and Vitamin E', 'description': '600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.077', 'spread': '0.062', 'groupId': 'OG000'}, {'value': '0.073', 'spread': '0.055', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'month 6', 'description': 'F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.'}, {'type': 'SECONDARY', 'title': 'Interleukin-6 (IL-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ALA and Vitamin E', 'description': '600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'spread': '15', 'groupId': 'OG000'}, {'value': '20', 'spread': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'month 6', 'description': 'IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants for analysis was based on those subjects who completed the 6-month study. Note that 8 subjects were excluded due to samples being lost. The analysis was per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ALA and Vitamin E', 'description': '600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '41'}]}]}], 'recruitmentDetails': 'This study was conducted at the Vanderbilt University Medical Center and at Fresenius Medical Care North America Dialysis clinics between April 2006 and September 2010.', 'preAssignmentDetails': 'There is a 1-month period between enrollment and assignment to a treatment group. Although 385 subjects were enrolled, only 356 were randomized (29 subjects withdrew consent prior to randomization). Also, 31 subjects were administratively withdrawn (due to widespread protocol non-compliance at one site) leaving 325 subjects assigned to a group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ALA and Vitamin E', 'description': '600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '12', 'groupId': 'BG000'}, {'value': '58', 'spread': '13', 'groupId': 'BG001'}, {'value': '58', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 385}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-09', 'studyFirstSubmitDate': '2005-10-10', 'resultsFirstSubmitDate': '2011-09-01', 'studyFirstSubmitQcDate': '2005-10-10', 'lastUpdatePostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-01', 'studyFirstPostDateStruct': {'date': '2005-10-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'F2-isoprostane (F2-iso)', 'timeFrame': 'month 6', 'description': 'F2-iso is a sensitive laboratory assay for serum levels of F2-isoprostane, which is a biomarker of oxidative stress.'}], 'secondaryOutcomes': [{'measure': 'Interleukin-6 (IL-6)', 'timeFrame': 'month 6', 'description': 'IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['End-stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Studies have shown that end stage renal disease (ESRD) patients have higher levels of blood markers which their body makes in response to increased stress and injury. An increase in these markers have been shown to be related to cardiovascular disease and death in ESRD patients. This study will examine whether antioxidant therapy (Vitamin E and alpha lipoic acid) may decrease these markers.', 'detailedDescription': 'Oxidative stress and acute phase inflammation are now recognized to be highly prevalent in the hemodialysis population, and several lines of evidence point to their contribution in atherosclerosis development. Biomarkers of the inflammatory state such as C-reactive protein (CRP) and interleukin-6 are robust predictors of cardiovascular events and mortality in the dialysis population. The uremic state is characterized by retention of oxidized solutes including reactive aldehyde groups and oxidized thiol groups. It has recently been demonstrated that initiation of maintenance hemodialysis does not improve biomarkers of oxidative stress or inflammation, suggesting that dialysis alone is inadequate to control the atherosclerotic uremic metabolic state. In this study we hypothesize that administration of antioxidant therapy will decrease biomarkers of acute phase inflammation and oxidative stress while improving the erythropoietic response in hemodialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with end-stage renal disease receiving thrice weekly hemodialysis\n2. Age \\> 18 years\n3. Life expectancy greater than one year\n4. Ability to understand and provide informed consent for participation in the study\n\nExclusion Criteria:\n\n1. AIDS (HIV seropositivity is not an exclusion criteria)\n2. Active malignancy excluding basal cell carcinoma of the skin\n3. Gastrointestinal dysfunction requiring parenteral nutrition\n4. History of functional kidney transplant \\< 6 months prior to study entry\n5. Anticipated live donor kidney transplant over study duration\n6. History of poor adherence to hemodialysis or medical regimen\n7. Prisoners, patients with significant mental illness, pregnant women, and other vulnerable populations\n8. Patients taking vitamin E supplements \\> 60 IU/day, vitamin C \\> 500 mg/day over the past 30 days\n9. Patients taking anti-inflammatory medication except aspirin \\< 325 mg/day over the past 30 days\n10. Patients using a temporary catheter for dialysis access\n11. More than two hospitalizations within the last 90 days or one hospitalization within the last 30 days'}, 'identificationModule': {'nctId': 'NCT00237718', 'briefTitle': 'Provision of Antioxidant Therapy in Hemodialysis (PATH) Study', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Provision of Antioxidant Therapy in Hemodialysis (PATH) Study', 'orgStudyIdInfo': {'id': '050377'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ALA and Vitamin E', 'description': '600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of alpha, gamma, beta and delta (mixed) tocopherols (Vitamin E) taken orally on a daily basis for 6 months', 'interventionNames': ['Drug: Alpha, gamma, beta, and delta (mixed) tocopherols', 'Drug: Alpha lipoic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Alpha, gamma, beta, and delta (mixed) tocopherols', 'type': 'DRUG', 'otherNames': ['Vitamin E'], 'description': 'approximately 666 IU daily (1 pill) for 6 months', 'armGroupLabels': ['ALA and Vitamin E']}, {'name': 'Alpha lipoic acid', 'type': 'DRUG', 'description': '600 mg daily (2 pills 300 mg each) for 6 months', 'armGroupLabels': ['ALA and Vitamin E']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo for alpha, gamma, beta, and delta (mixed) tocopherols; 1 pill daily for 6 months', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo for alpha lipoic acid; 2 pills daily for 6 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Fresenius Medical Care North America', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Jonathan Himmelfarb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MaineHealth'}, {'name': 'Alp Ikizler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fresenius Medical Care North America', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alp Ikizler', 'investigatorAffiliation': 'Vanderbilt University'}}}}