At a glance
ClinicalIndex Comparison RecordN/ACompleted· 341 enrolled
Drug / intervention
5-MTHF (5-methyltetrahydrofolate) +1 moredrug
Likely dose
5-MTHF (5-methyltetrahydrofolate) 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
5-methyltetrahydrofolate Survival and Inflammation in ESRD Patients
IRCCS Azienda Ospedaliero-Universitaria di Bologna·interventional·Posted Feb 29, 2008·Updated Mar 18, 2021
In Brief
A clinical study evaluating 5-MTHF (5-methyltetrahydrofolate) and folic acid for Mortality and 2 related conditions. Completed, enrolled 341 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMortality, Hyperhomocysteinemia, Inflammation
CountriesItaly
CollaboratorsUniversity of Bologna
Timeline
N/ACompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 1998
Primary CompletionJul 2001
Study CompletionJul 2007
First PostedFeb 2008
TodayJul 2026
First PostedFeb 29, 2008
Enrollment StartJan 1, 1998
Primary CompletionJul 1, 2001
Study CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.3 years ago
Interventions
5-MTHF (5-methyltetrahydrofolate)drug
50 mg intravenous at the end of each hemodialysis session
folic aciddrug
5 mg per day of oral folic acid