MortalityNCT00626223
5-methyltetrahydrofolate Survival and Inflammation in ESRD Patients
A study testing 5-MTHF (5-methyltetrahydrofolate) and folic acid in people with Mortality and Hyperhomocysteinemia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mortality, Hyperhomocysteinemia, Inflammation
- What is being tested?
- 5-MTHF (5-methyltetrahydrofolate) and folic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteItaly
- Study dates
- Jan 1998to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- Diagnosis of one of the following clinical conditions in the last three months:
- acute infection
- vascular access thrombosis
- ictus cerebri
- myocardial infarction
- hemorrhage
Show all 9Show fewer
- recent relevant surgery
- Malignancy
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Italy1 site
Nephrology Dialysis and Renal Transplantation Unit, S.Orsola University Hospital
Bologna, 40138
About this study
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.
Read the detailed description
BACKGROUND Hemodialysis patients show a 20-fold increase in CVD mortality in comparison to the general population.
Although hyperhomocysteinemia has been implicated as an important independent risk factor in both the general population2, as well as for ESRD patients, several studies have questioned the benefit of lowering homocysteine in ESRD patients. Paradoxically, two recent studies showed that patients with very low homocysteine plasma levels had worse outcomes including a higher incidence of hospitalization and mortality. This raises the question as to whether elevated homocysteine in uremic patients is consequential rather than causal in the role of cardiovascular complications.
Despite this uncertainty, many ESRD and pre-ESRD patients receive treatment to lower homocysteine. Elevated homocysteine is frequently reported for ESRD patients with a prevalence ranging from 85 to 100%.
There are two basic strategies that can be used to lower homocysteine. Both attempt to increase levels of biologically active folate which is essential in the remethylation pathway of homocysteine metabolism via its active metabolite 5-methyltetrahydrofolate (5-MTHF), thus lowering homocysteine efflux from tissues into the plasma compartment.
The first, and most common approach, is by oral administration of folic acid. Folic acid is not biologically active, however it is more stable than folate, and is often used in tablets and food fortification. The second approach is to supplement 5-MTHF, the natural circulating form of folate. In addition to folate, both vitamin B6 and vitamin B12 are necessary co-factors in homocysteine metabolism. ESRD patients are often resistant to homocysteine lowering by administration of both folic acid and 5-MTHF.
Although supplementation with folic acid, B6 and B12 usually decreases homocysteine in patients with vascular disease, it often remains elevated in ESRD patients despite supplementation of folic acid, B6 and B12. Several studies have reported only moderate effects, even with very high doses of folic acid (up to 15 mg/daily).
AIM OF THE STUDY The aim of this study is to investigate whether supplementation with 5MTHF vs. folic acid treatment affects patient survival. Homocysteine blood levels and MTHFR genetic polymorphisms will also be evaluated to determine if they can be considered as independent cardiovascular risk factors.
STUDY DESIGN Single center, randomised, prospective study. Two groups of stable ESRD patients treated with intravenous 5-MTHF or with 5 mg per day of oral folic acid.
Patient selection Period of selection : 4 years Start selection : 1 January 1998 End selection: 30 June 2001 Follow-up: 55 months.
STATISTICAL ANALYSIS Statistical analysis will be performed by the Statistical Package for the Social Sciences (SPSS).
- Conditions
- Mortality, Hyperhomocysteinemia, Inflammation
- Being tested
- 5-MTHF (5-methyltetrahydrofolate), folic acid
- Keywords
- ESRD patients, C-reactive protein, homocysteine, 5-MTHF, survival, Hemodialysis patients
- Medical subject headings
- Hyperhomocysteinemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | patients treated with intravenous 5-MTHF (Prefolic®, Knoll, Milan, Italy) 50 mg at the end of each hemodialysis session; The group will receive supplementation with vitamin B6 300 mg (Benadon®, Roche, Milan, Italy) and vitamin B12 1000 mcg (Dobetin®, A.C.R.A.F, Rome, Italy) administered by intravenous injection at the end of the hemodialysis session three times per week Receives: Drug: 5-MTHF (5-methyltetrahydrofolate) |
| B | Active comparator | treated with 5 mg per day of oral folic acid (Folina® Schwarz Pharma, Milan, Italy).
The group will receive supplementation with vitamin B6 300 mg (Benadon®, Roche, Milan, Italy) and vitamin B12 1000 mcg (Dobetin®, A.C.R.A.F, Rome, Italy) administered by intravenous injection at the end of the hemodialysis session three times per week Receives: Drug: folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Measured: 55 months
Secondary outcomes (5)
Risk factors for cardiovascular disease in ESRD patients
Measured: 55 months
Homocysteine levels after 6, 12, 24 and 55 months
Measured: 55 months
CRP levels after 6, 12, 24 and 55 months
Measured: 55 months
Gene polymorphisms analysis on C677T and A1298C loci and differences in polymorphisms distribution in both groups
Measured: basal
Differences at baseline between the groups concerning age, dialysis age, CRP, albumin, haemoglobin, Lp(a), homocysteine, folate, B6 and B12 baseline levels
Measured: basal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJan 1998
- Primary completionJul 2001
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for MortalityStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Investigators
- Sergio Stefoni, Professor, Study chair, Nephrology Dialysis and Renal Trasnplantation Unit S.Orsola University Hospital Bologna Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626223
- Sponsor's protocol ID
- FCRB 2007/0234
- Other IDs
- ndtso 00025/2007
- Status last verified
- Mar 2021
- First submitted
- 4 Feb 2008
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheung AK, Sarnak MJ, Yan G, Berkoben M, Heyka R, Kaufman A, Lewis J, Rocco M, Toto R, Windus D, Ornt D, Levey AS; HEMO Study Group. Cardiac diseases in maintenance hemodialysis patients: results of the HEMO Study. Kidney Int. 2004 Jun;65(6):2380-9. doi: 10.1111/j.1523-1755.2004.00657.x.
PubMed 15149351Nygard O, Vollset SE, Refsum H, Stensvold I, Tverdal A, Nordrehaug JE, Ueland M, Kvale G. Total plasma homocysteine and cardiovascular risk profile. The Hordaland Homocysteine Study. JAMA. 1995 Nov 15;274(19):1526-33. doi: 10.1001/jama.1995.03530190040032.
PubMed 7474221Buccianti G, Baragetti I, Bamonti F, Furiani S, Dorighet V, Patrosso C. Plasma homocysteine levels and cardiovascular mortality in patients with end-stage renal disease. J Nephrol. 2004 May-Jun;17(3):405-10.
PubMed 15365961Mallamaci F, Bonanno G, Seminara G, Rapisarda F, Fatuzzo P, Candela V, Scudo P, Spoto B, Testa A, Tripepi G, Tech S, Zoccali C. Hyperhomocysteinemia and arteriovenous fistula thrombosis in hemodialysis patients. Am J Kidney Dis. 2005 Apr;45(4):702-7. doi: 10.1053/j.ajkd.2005.01.004.
PubMed 15806473Perna AF, De Santo NG, Ingrosso D. Adverse effects of hyperhomocysteinemia and their management by folic acid. Miner Electrolyte Metab. 1997;23(3-6):174-8.
PubMed 9387111Kalantar-Zadeh K, Block G, Humphreys MH, McAllister CJ, Kopple JD. A low, rather than a high, total plasma homocysteine is an indicator of poor outcome in hemodialysis patients. J Am Soc Nephrol. 2004 Feb;15(2):442-53. doi: 10.1097/01.asn.0000107564.60018.51.
PubMed 14747392Nair AP, Nemirovsky D, Kim M, Geer EB, Farkouh ME, Winston J, Halperin JL, Robbins MJ. Elevated homocysteine levels in patients with end-stage renal disease. Mt Sinai J Med. 2005 Nov;72(6):365-73.
PubMed 16358160Bayes B, Pastor MC, Bonal J, Junca J, Hernandez JM, Riutort N, Foraster A, Romero R. Homocysteine, C-reactive protein, lipid peroxidation and mortality in haemodialysis patients. Nephrol Dial Transplant. 2003 Jan;18(1):106-12. doi: 10.1093/ndt/18.1.106.
PubMed 12480967Bowden RG, Wyatt FB, Wilson R, Wilborn C, Gentile M. Homocysteine and vascular access thrombosis in a cohort of end-stage renal disease patients. Ren Fail. 2004 Nov;26(6):709-14. doi: 10.1081/jdi-200037117.
PubMed 15600264Chen TC, Wang IK, Lee CH, Chang HW, Chiou TT, Lee CT, Fang JT, Wu MS, Hsu KT, Yang CC, Wang PH, Chuang FR. Hyperhomocysteinaemia and vascular access thrombosis among chronic hemodialysis patients in Taiwan: a retrospective study. Int J Clin Pract. 2006 Dec;60(12):1596-9. doi: 10.1111/j.1742-1241.2006.00848.x. Epub 2006 May 16.
PubMed 16704682Chuang FR, Fang JT, Chen JB, Lin CL, Chen HY, Lee CN, Wang PH, Lee CH. Hyperhomocystinemia and the prevalence of symptomatic atherosclerotic vascular disease in Taiwanese chronic hemodialysis patients: a retrospective study. Ren Fail. 2003 Sep;25(5):765-74. doi: 10.1081/jdi-120024292.
PubMed 14575285Dennis VW, Robinson K. Homocysteinemia and vascular disease in end-stage renal disease. Kidney Int Suppl. 1996 Dec;57:S11-7.
PubMed 8941916Suliman ME, Stenvinkel P, Heimburger O, Barany P, Lindholm B, Bergstrom J. Plasma sulfur amino acids in relation to cardiovascular disease, nutritional status, and diabetes mellitus in patients with chronic renal failure at start of dialysis therapy. Am J Kidney Dis. 2002 Sep;40(3):480-8. doi: 10.1053/ajkd.2002.34887.
PubMed 12200798Bonaa KH, Njolstad I, Ueland PM, Schirmer H, Tverdal A, Steigen T, Wang H, Nordrehaug JE, Arnesen E, Rasmussen K; NORVIT Trial Investigators. Homocysteine lowering and cardiovascular events after acute myocardial infarction. N Engl J Med. 2006 Apr 13;354(15):1578-88. doi: 10.1056/NEJMoa055227. Epub 2006 Mar 12.
PubMed 16531614Lonn E, Yusuf S, Arnold MJ, Sheridan P, Pogue J, Micks M, McQueen MJ, Probstfield J, Fodor G, Held C, Genest J Jr; Heart Outcomes Prevention Evaluation (HOPE) 2 Investigators. Homocysteine lowering with folic acid and B vitamins in vascular disease. N Engl J Med. 2006 Apr 13;354(15):1567-77. doi: 10.1056/NEJMoa060900. Epub 2006 Mar 12.
PubMed 16531613
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-methyltetrahydrofolate Survival and Inflammation in ESRD Patients
- ClinicalTrials.gov ID
- NCT00626223
- Acronym / sponsor ID
- FCRB 2007/0234
- Conditions
- Mortality, Hyperhomocysteinemia, Inflammation
- Keywords
- ESRD patients, C-reactive protein, homocysteine, 5-MTHF, survival, Hemodialysis patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- Jan 1998
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND Hemodialysis patients show a 20-fold increase in CVD mortality in comparison to the general population.
Although hyperhomocysteinemia has been implicated as an important independent risk factor in both the general population2, as well as for ESRD patients, several studies have questioned the benefit of lowering homocysteine in ESRD patients. Paradoxically, two recent studies showed that patients with very low homocysteine plasma levels had worse outcomes including a higher incidence of hospitalization and mortality. This raises the question as to whether elevated homocysteine in uremic patients is consequential rather than causal in the role of cardiovascular complications.
Despite this uncertainty, many ESRD and pre-ESRD patients receive treatment to lower homocysteine. Elevated homocysteine is frequently reported for ESRD patients with a prevalence ranging from 85 to 100%.
There are two basic strategies that can be used to lower homocysteine. Both attempt to increase levels of biologically active folate which is essential in the remethylation pathway of homocysteine metabolism via its active metabolite 5-methyltetrahydrofolate (5-MTHF), thus lowering homocysteine efflux from tissues into the plasma compartment.
The first, and most common approach, is by oral administration of folic acid. Folic acid is not biologically active, however it is more stable than folate, and is often used in tablets and food fortification. The second approach is to supplement 5-MTHF, the natural circulating form of folate. In addition to folate, both vitamin B6 and vitamin B12 are necessary co-factors in homocysteine metabolism. ESRD patients are often resistant to homocysteine lowering by administration of both folic acid and 5-MTHF.
Although supplementation with folic acid, B6 and B12 usually decreases homocysteine in patients with vascular disease, it often remains elevated in ESRD patients despite supplementation of folic acid, B6 and B12. Several studies have reported only moderate effects, even with very high doses of folic acid (up to 15 mg/daily).
AIM OF THE STUDY The aim of this study is to investigate whether supplementation with 5MTHF vs. folic acid treatment affects patient survival. Homocysteine blood levels and MTHFR genetic polymorphisms will also be evaluated to determine if they can be considered as independent cardiovascular risk factors.
STUDY DESIGN Single center, randomised, prospective study. Two groups of stable ESRD patients treated with intravenous 5-MTHF or with 5 mg per day of oral folic acid.
Patient selection Period of selection : 4 years Start selection : 1 January 1998 End selection: 30 June 2001 Follow-up: 55 months.
STATISTICAL ANALYSIS Statistical analysis will be performed by the Statistical Package for the Social Sciences (SPSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 5-MTHF (5-methyltetrahydrofolate)patients treated with intravenous 5-MTHF (Prefolic®, Knoll, Milan, Italy) 50 mg at the end of each hemodialysis session; The group will receive supplementation with vitamin B6 300 mg (Benadon®, Roche, Milan, Italy) and vitamin B12 1000 mcg (Dobetin®, A.C.R.A.F, Rome, Italy) administered by intravenous injection at the end of the hemodialysis session three times per week |
| B | Active comparator | Drug: folic acidtreated with 5 mg per day of oral folic acid (Folina® Schwarz Pharma, Milan, Italy). The group will receive supplementation with vitamin B6 300 mg (Benadon®, Roche, Milan, Italy) and vitamin B12 1000 mcg (Dobetin®, A.C.R.A.F, Rome, Italy) administered by intravenous injection at the end of the hemodialysis session three times per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- Diagnosis of one of the following clinical conditions in the last three months:
- Malignancy
- Participation in other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-MTHF (5-methyltetrahydrofolate)50 mg intravenous at the end of each hemodialysis session | Drug | A |
| folic acid5 mg per day of oral folic acid | Drug | B |
Primary outcome
survival
Time frame: 55 months
5 secondary outcomes
Risk factors for cardiovascular disease in ESRD patients
Time frame: 55 months
Homocysteine levels after 6, 12, 24 and 55 months
Time frame: 55 months
CRP levels after 6, 12, 24 and 55 months
Time frame: 55 months
Gene polymorphisms analysis on C677T and A1298C loci and differences in polymorphisms distribution in both groups
Time frame: basal
Differences at baseline between the groups concerning age, dialysis age, CRP, albumin, haemoglobin, Lp(a), homocysteine, folate, B6 and B12 baseline levels
Time frame: basal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 15149351Cheung AK, Sarnak MJ, Yan G, Berkoben M, Heyka R, Kaufman A, Lewis J, Rocco M, Toto R, Windus D, Ornt D, Levey AS; HEMO Study Group. Cardiac diseases in maintenance hemodialysis patients: results of the HEMO Study. Kidney Int. 2004 Jun;65(6):2380-9. doi: 10.1111/j.1523-1755.2004.00657.x.
- Background: PubMed 7474221Nygard O, Vollset SE, Refsum H, Stensvold I, Tverdal A, Nordrehaug JE, Ueland M, Kvale G. Total plasma homocysteine and cardiovascular risk profile. The Hordaland Homocysteine Study. JAMA. 1995 Nov 15;274(19):1526-33. doi: 10.1001/jama.1995.03530190040032.
- Background: PubMed 15365961Buccianti G, Baragetti I, Bamonti F, Furiani S, Dorighet V, Patrosso C. Plasma homocysteine levels and cardiovascular mortality in patients with end-stage renal disease. J Nephrol. 2004 May-Jun;17(3):405-10.
- Background: PubMed 15806473Mallamaci F, Bonanno G, Seminara G, Rapisarda F, Fatuzzo P, Candela V, Scudo P, Spoto B, Testa A, Tripepi G, Tech S, Zoccali C. Hyperhomocysteinemia and arteriovenous fistula thrombosis in hemodialysis patients. Am J Kidney Dis. 2005 Apr;45(4):702-7. doi: 10.1053/j.ajkd.2005.01.004.
- Background: PubMed 9387111Perna AF, De Santo NG, Ingrosso D. Adverse effects of hyperhomocysteinemia and their management by folic acid. Miner Electrolyte Metab. 1997;23(3-6):174-8.
- Background: PubMed 14747392Kalantar-Zadeh K, Block G, Humphreys MH, McAllister CJ, Kopple JD. A low, rather than a high, total plasma homocysteine is an indicator of poor outcome in hemodialysis patients. J Am Soc Nephrol. 2004 Feb;15(2):442-53. doi: 10.1097/01.asn.0000107564.60018.51.
- Background: PubMed 16358160Nair AP, Nemirovsky D, Kim M, Geer EB, Farkouh ME, Winston J, Halperin JL, Robbins MJ. Elevated homocysteine levels in patients with end-stage renal disease. Mt Sinai J Med. 2005 Nov;72(6):365-73.
- Background: PubMed 12480967Bayes B, Pastor MC, Bonal J, Junca J, Hernandez JM, Riutort N, Foraster A, Romero R. Homocysteine, C-reactive protein, lipid peroxidation and mortality in haemodialysis patients. Nephrol Dial Transplant. 2003 Jan;18(1):106-12. doi: 10.1093/ndt/18.1.106.
- Background: PubMed 15600264Bowden RG, Wyatt FB, Wilson R, Wilborn C, Gentile M. Homocysteine and vascular access thrombosis in a cohort of end-stage renal disease patients. Ren Fail. 2004 Nov;26(6):709-14. doi: 10.1081/jdi-200037117.
- Background: PubMed 16704682Chen TC, Wang IK, Lee CH, Chang HW, Chiou TT, Lee CT, Fang JT, Wu MS, Hsu KT, Yang CC, Wang PH, Chuang FR. Hyperhomocysteinaemia and vascular access thrombosis among chronic hemodialysis patients in Taiwan: a retrospective study. Int J Clin Pract. 2006 Dec;60(12):1596-9. doi: 10.1111/j.1742-1241.2006.00848.x. Epub 2006 May 16.
- Background: PubMed 14575285Chuang FR, Fang JT, Chen JB, Lin CL, Chen HY, Lee CN, Wang PH, Lee CH. Hyperhomocystinemia and the prevalence of symptomatic atherosclerotic vascular disease in Taiwanese chronic hemodialysis patients: a retrospective study. Ren Fail. 2003 Sep;25(5):765-74. doi: 10.1081/jdi-120024292.
- Background: PubMed 8941916Dennis VW, Robinson K. Homocysteinemia and vascular disease in end-stage renal disease. Kidney Int Suppl. 1996 Dec;57:S11-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Stefoni, Professor study chair
Nephrology Dialysis and Renal Trasnplantation Unit S.Orsola University Hospital Bologna Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-MTHF (5-methyltetrahydrofolate) and folic acid in people with Mortality and Hyperhomocysteinemia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival (time frame: 55 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00626223, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.