Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT00317005
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2006-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Uremic Hyperhomocysteinemia -A Folate Trial for Possible Prevention of Cardiovascular Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014511', 'term': 'Uremia'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D020138', 'term': 'Hyperhomocysteinemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'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': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-05', 'completionDateStruct': {'date': '2005-03'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2006-04-18', 'studyFirstSubmitQcDate': '2006-04-20', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-04-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lowering of Homocysteine blood levels in uremia.'}, {'measure': 'Prevention of cardiovascular events'}], 'secondaryOutcomes': [{'measure': 'Reduction of carotid intima-media thickness'}]}, 'conditionsModule': {'keywords': ['hemodialysis', 'chronic uremia', 'hyperhomocysteinemia', 'folate'], 'conditions': ['Uremia', 'Chronic Renal Failure', 'Hemodialysis', 'Hyperhomocysteinemia', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '10456270', 'type': 'BACKGROUND', 'citation': 'Brenner RM, Wrone EM. The epidemic of cardiovascular disease in end-stage renal disease. Curr Opin Nephrol Hypertens. 1999 May;8(3):365-9. doi: 10.1097/00041552-199905000-00015. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Homocysteine recently gained access to the category of risk factor for the development of atherosclerotic cardiovascular disease in the general population. Chronic renal failure patients, even before being introduced to dialysis therapy have almost universal elevation of serum homocysteine; when on dialysis their mortality is above 50% related to cardiovascular disease that we might now speculate, with a contribution of potentially toxic levels of the aminoacid homocysteine.', 'detailedDescription': 'We conducted a double blind , randomized, placebo controlled trial, for two years, enroling, simultaneously, 186 end-stage kidney disease patients of any cause, older than 18 years of age, stable on hemodialysis, assigned to receive either oral folic acid 10 mg three times a week on post dialysis sessions, under nurse supervision or an identical appearing placebo for the entire lenght of the study, from april 2003 to march 2005.\n\nThe two groups had similar baseline clinical and laboratory characteristics. There was no loss of follow-up. At admission, homocysteine serum levels were above 13,9 umol/L in 96.7% (median 25.0, range 9.3-104.0)with only five cases in the normal levels; homocysteine remained elevated at 6, 12 and 24 months on those receiving placebo; folate treatment significantly decreased total homocysteine levels to a median value of 10.5 umol/L (2.8 - 20.3)which remained at this level for the entire study time (P\\<0.001); every one was alive and tested at six months, sixty eight were either transplanted(15)or died (53) from cardiovascular disease(seventeen in the folic acid group and twenty one in the placebo (P\\>0.05)or other causes(15), after being included in the study. Intima-media wall thickness blinded measured at the common carotid artery decreased from 1.94+-0,59 mm to 1.67+-0.38 (P\\<0.001) with folate therapy and became thicker, from 1.86+-0.41 to 2.11+-0.48 mm in the placebo group.\n\nIn conclusion, folate treatment for two years was not effective on modifying cardiovascular death and non fatal cardiovascular events of this sample population with chronic uremia; however, the ultrasonographic evaluation of the common carotid arteries intima-media wall thickness at entry and twenty four months later unequivocally showed a significant thickness decrease with supervised folate intake.\n\nEarlier prescription of folic acid might benefit patients with chronic renal failure,preventing cardiovascular deterioration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients stable on hemodialysis for 4 months or more\n* Eighteen years of age or older\n\nExclusion Criteria:\n\n* Potential kidney transplant from a living donor in the near future\n* Severe cardiovascular disease\n* Cancer and active inflammation'}, 'identificationModule': {'nctId': 'NCT00317005', 'briefTitle': 'Uremic Hyperhomocysteinemia -A Folate Trial for Possible Prevention of Cardiovascular Events', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual de Londrina'}, 'officialTitle': 'Randomized Clinical Trial of Folate Therapy/Placebo for Reduction of Homocysteine Serum Levels in Uremic Patients and Influence on Cardiovascular Mortality', 'orgStudyIdInfo': {'id': 'UEL/CPG/Nefro/Hcy'}}, 'armsInterventionsModule': {'interventions': [{'name': 'folate treatment', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86020-320', 'city': 'Londrina', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Universitario regional do Note do Parana', 'geoPoint': {'lat': -23.31028, 'lon': -51.16278}}, {'zip': '86020-320', 'city': 'Londrina', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'University Hospital, State University of Londrina', 'geoPoint': {'lat': -23.31028, 'lon': -51.16278}}], 'overallOfficials': [{'name': 'Altair J Mocelin, MD PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nephrology, University Hospital, State University of Londrina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual de Londrina', 'class': 'OTHER'}}}}