5-methyltetrahydrofolate Survival and Inflammation in ESRD Patients

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna; St. Orsola Hospital
• Collaborator: University of Bologna
• Treatments: Folic Acid; Tetrahydrofolates; Vitamin B Complex

Criteria

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 or by angiographic/Doppler documentation of atherosclerotic plaques in abdominal, iliac and femoral vessels). The vascular surgical procedure will be carried out at least three months before the study started.

Exclusion Criteria:

• Diagnosis of one of the following clinical conditions in the last three months:

• acute infection

• vascular access thrombosis

• ictus cerebri

• myocardial infarction

• hemorrhage

• recent relevant surgery

• Malignancy

• Participation in other clinical trials