Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-27 @ 11:26 AM
Study NCT ID:
NCT00032435
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2002-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Homocysteine Study (HOST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2003}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-14', 'studyFirstSubmitDate': '2002-03-20', 'studyFirstSubmitQcDate': '2002-03-21', 'lastUpdatePostDateStruct': {'date': '2010-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['folate', 'pyridoxine', 'vitamin B6', 'cyanocobalamin', 'homoc'], 'conditions': ['End Stage Renal Disease', 'Renal Failure']}, 'referencesModule': {'references': [{'pmid': '19628319', 'type': 'DERIVED', 'citation': 'Brady CB, Gaziano JM, Cxypoliski RA, Guarino PD, Kaufman JS, Warren SR, Hartigan P, Goldfarb DS, Jamison RL. Homocysteine lowering and cognition in CKD: the Veterans Affairs homocysteine study. Am J Kidney Dis. 2009 Sep;54(3):440-9. doi: 10.1053/j.ajkd.2009.05.013. Epub 2009 Jul 23.'}, {'pmid': '19272686', 'type': 'DERIVED', 'citation': 'Jamison RL, Shih MC, Humphries DE, Guarino PD, Kaufman JS, Goldfarb DS, Warren SR, Gaziano JM, Lavori P; Veterans Affairs Site Investigators. Effect of the MTHFR C677T and A1298C polymorphisms on survival in patients with advanced CKD and ESRD: a prospective study. Am J Kidney Dis. 2009 May;53(5):779-89. doi: 10.1053/j.ajkd.2008.12.023. Epub 2009 Mar 9.'}, {'pmid': '17848650', 'type': 'DERIVED', 'citation': 'Jamison RL, Hartigan P, Kaufman JS, Goldfarb DS, Warren SR, Guarino PD, Gaziano JM; Veterans Affairs Site Investigators. Effect of homocysteine lowering on mortality and vascular disease in advanced chronic kidney disease and end-stage renal disease: a randomized controlled trial. JAMA. 2007 Sep 12;298(10):1163-70. doi: 10.1001/jama.298.10.1163.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and the death rate compared to patients who receive placebo. The secondary objective is to test the hypothesis that intake of the vitamins compared to placebo decreases the incidence of myocardial infarction, disabling stroke, and amputation of a lower extremity and, in hemodialysis patients, thrombosis of the vascular access.', 'detailedDescription': 'Primary Hypothesis:\n\nThe primary objective of this proposal is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end-stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and increase survival.\n\nSecondary Hypotheses:\n\nThe secondary objectives are to test the hypotheses that intake of the vitamins decreases: 1) MI, 2) stroke, 3) amputation of lower extremity, 4) combination death, MI, stroke and amputation of lower extremity, 5) thrombosis of the vascular access in hemodialysis patients.\n\nPrimary Outcome: Death\n\nInterventions: A treated group that receives a daily tablet containing 40mg of folic acid, 100mg of pyridoxine and 2mg of B12 versus a control group that receives a placebo.\n\nStudy Abstract:\n\nThe experimental design is a prospective, two-arm, randomized, double blind study, stratified for medical center and whether the patient has chronic renal failure or end-stage renal disease. In each arm 1003 patients will ingest daily a capsule containing either 40mg of folic acid, 100mg of pyridoxine and 2mg of vitamin B12, or placebo. We will use stratified randomization to ensure that the treatment is balanced within the end-stage renal disease patients and chronic renal failure patients.\n\nThis 6 year study will require an accrual phase of 2 years and a treatment phase lasting a minimum of 4 years. Patients will be screened by their plasma homocysteine concentration. They must have a level of at least 15 uM/L to be enrolled in the study. The study nurse will evaluate each patient at 3 months. Thereafter, patients will be contacted by phone, or mail if they prefer, at 3-month intervals by coordinators at a central location. Secondary endpoint events, hospitalization, onset of dialysis, and death or other reason for exit from the study will be recorded on standard forms. Plasma homocysteine levels will be obtained at 3 months in all patients.\n\nPatients will be excluded if: age less than 21 years, expected life span less than 6 months, pregnancy, metastatic cancer, AIDS-related infection, end-stage liver disease, vitamin B12 deficiency, treatment with methotrexate, or anticonvulsants, unreliable or likely non-compliant, participation in other long-term trial, or unwilling or unable to give informed consent.\n\nFor a relative treatment effect of 17% (that is reducing the 3-year death rate from 28% to 23.2%) and 80% power, 2006 patients and 36 VA medical centers are required.\n\nAn abundance of published reports has shown a strong correlation between homocysteinemia and the incidence of cardiovascular death. Authors of these papers have unanimously recommended a study be undertaken to determine if folate, pyridoxine, and vitamin B12 can lower the incidence.\n\nThe study is to be conducted in patients with chronic renal failure and end-stage renal disease whose plasma homocysteine levels and incidence of cardiovascular death and disease are among the highest of all patient populations. By screening for patients with high plasma homocysteine concentrations and measuring the levels after 3 months, we will be able to determine if the hypothetical reduction in death and cardiovascular event rate is associated with a decrease in plasma homocysteine concentration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients will be screened by their plasma homocysteine concentration. They must have a level of at least 15 mM/L to be enrolled in the study.\n\nPatients will be excluded by any of the following criteria: age less than 21 years, expected life span less than 6 months, pregnancy, metastatic cancer, end-stage liver disease, treatment with methotrexate, other anti-folate medication or anticonvulsants, unreliable or likely noncompliant, participation in another long-term trial, or unwilling or unable to give informed consent.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT00032435', 'briefTitle': 'Homocysteine Study (HOST)', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'CSP #453 - Homocysteinemia in Kidney and Endstage Renal Disease Study (HOST)', 'orgStudyIdInfo': {'id': '453'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'PAL-40 Active', 'interventionNames': ['Drug: PAL-40 Active']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'PAL-40 Placebo', 'interventionNames': ['Drug: PAL-40 Placebo']}], 'interventions': [{'name': 'PAL-40 Active', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'PAL-40 Placebo', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'VA Medical Center, Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94025', 'city': 'Menlo Park', 'state': 'California', 'country': 'United States', 'facility': 'Health Economics Resource Center (HERC), Menlo Park', 'geoPoint': {'lat': 37.45383, 'lon': -122.18219}}, {'zip': '94304-1290', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'VA Eastern Colorado Health Care System, Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'VA Connecticut Health Care System (West Haven)', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'VA Medical Center, DC', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33708', 'city': 'Bay Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'VA Medical Center, Bay Pines', 'geoPoint': {'lat': 27.81419, 'lon': -82.77816}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida/South Georgia Veterans Health System', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'VA Medical Center, Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33410', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'West Palm Beach VA Medical Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60141-5000', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hines, Jr. VA Hospital', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}, {'zip': '46202-2884', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Richard Roudebush VA Medical Center, Indianapolis', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Southeast Veterans Healthcare System, New Orleans', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'VA Medical Center, Jamaica Plain Campus', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48113', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'John D. Dingell VA Medical Center, Detroit', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'VA Medical Center, Minneapolis', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'G.V. (Sonny) Montgomery VA Medical Center, Jackson', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'VA Medical Center, Kansas City MO', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'VA Western New York Healthcare System at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Harbor HCS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11768', 'city': 'Northport', 'state': 'New York', 'country': 'United States', 'facility': 'VA Medical Center, Northport', 'geoPoint': {'lat': 40.90093, 'lon': -73.34317}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'VA Medical Center, Syracuse', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'VA Medical Center, Bronx', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'VA Medical Center, Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45428', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'VA Medical Center, Dayton', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Medical Center, Portland', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15240', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'VA Pittsburgh Health Care System', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29401-5799', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H Johnson VA Medical Center, Charleston', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'VA Medical Center, Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'VA North Texas Health Care System, Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. DeBakey VA Medical Center (152)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System, Seattle', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53295-1000', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Zablocki VA Medical Center, Milwaukee', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '00921', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'VA Medical Center, San Juan', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Rex L. Jamison', 'role': 'STUDY_CHAIR', 'affiliation': 'VA Palo Alto Health Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'collaborators': [{'name': 'Pan American Laboratories', 'class': 'INDUSTRY'}, {'name': 'Abbott Diagnostics Division', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jamison, Rex - Study Chair', 'oldOrganization': 'Department of Veterans Affairs'}}}}