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5-methyltetrahydrofolate Survival and Inflammation in ESRD Patients

NCT00626223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2021-03-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

5-MTHF (5-methyltetrahydrofolate)

50 mg intravenous at the end of each hemodialysis session

DRUG

folic acid

5 mg per day of oral folic acid

Sponsors & Collaborators

  • University of Bologna

    collaborator OTHER

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Sergio Stefoni, Professor · Nephrology Dialysis and Renal Trasnplantation Unit S.Orsola University Hospital Bologna Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-01-31
Primary Completion
2001-07-31
Completion
2007-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00626223 on ClinicalTrials.gov