5-methyltetrahydrofolate Survival and Inflammation in ESRD Patients (NCT00626223) | Clinical Trial Compass
CompletedNot Applicable
5-methyltetrahydrofolate Survival and Inflammation in ESRD Patients
Italy341 participantsStarted 1998-01
Plain-language summary
A randomized prospective study was done to determine whether i.v. 5-methyltetrahydrofolate vs oral folate improved survival in ESRD patients. Homocysteine, CRP, Lp(a), albumin, folates, vitamin B6 and B12 were checked. The 5-MTHF treated group was associated with lowered C reactive protein and higher survival than the folate treated group.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Hemodialysis patients with age \> 18 years on regular bicarbonate hemodialysis or hemodiafiltration treatment three times a week
* Clinical stability at least three months before the study started
* Cardiovascular disease assessment as presence/absence of hypertension, ischemic cardiac disease, cerebral and peripheral vascular disease, diabetes.
* We will investigate coronary artery disease by determination of at least one of the following parameters:
* previous documentation of acute myocardial infarction (laboratory or ECG modifications);
* symptomatic CVD events in the clinical history confirmed by a positive treadmill test;
* coronary artery stenosis more than 50% in one of the three major coronary vessels documented by an angiographic study. All patients with coronary artery disease will be examined by a treadmill test (thallium scan) or coronary angiographic exam before entering the study.
* We will investigate cerebrovascular disease by one of the following criteria:
* a previous ictus (ongoing clinical evidence of neurological deficit in the three months before the study beginning, confirmed by a TC scan, a nuclear magnetic resonance or a physician's record of clinical history);
* carotid vessels stenosis more than 50% documented by a Doppler exam.
* Peripheral vascular disease will be assessed by the evidence of claudication intermittence, previous vascular surgical procedure (including amputation for ischemic limb …
What they're measuring
1
survival
Timeframe: 55 months
Trial details
NCT IDNCT00626223
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna