Uremic Hyperhomocysteinemia -A Folate Trial for Possible Prevention of Cardiovascular Events
Primary Purpose
Uremia, Chronic Renal Failure, Hemodialysis
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
folate treatment
Sponsored by
About this trial
This is an interventional prevention trial for Uremia focused on measuring hemodialysis, chronic uremia, hyperhomocysteinemia, folate
Eligibility Criteria
Inclusion Criteria: Patients stable on hemodialysis for 4 months or more Eighteen years of age or older Exclusion Criteria: Potential kidney transplant from a living donor in the near future Severe cardiovascular disease Cancer and active inflammation
Sites / Locations
- Hospital Universitario regional do Note do Parana
- University Hospital, State University of Londrina
Outcomes
Primary Outcome Measures
Lowering of Homocysteine blood levels in uremia.
Prevention of cardiovascular events
Secondary Outcome Measures
Reduction of carotid intima-media thickness
Full Information
NCT ID
NCT00317005
First Posted
April 18, 2006
Last Updated
July 23, 2018
Sponsor
Universidade Estadual de Londrina
1. Study Identification
Unique Protocol Identification Number
NCT00317005
Brief Title
Uremic Hyperhomocysteinemia -A Folate Trial for Possible Prevention of Cardiovascular Events
Official Title
Randomized Clinical Trial of Folate Therapy/Placebo for Reduction of Homocysteine Serum Levels in Uremic Patients and Influence on Cardiovascular Mortality
Study Type
Interventional
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Estadual de Londrina
4. Oversight
5. Study Description
Brief Summary
Homocysteine recently gained access to the category of risk factor for the development of atherosclerotic cardiovascular disease in the general population. Chronic renal failure patients, even before being introduced to dialysis therapy have almost universal elevation of serum homocysteine; when on dialysis their mortality is above 50% related to cardiovascular disease that we might now speculate, with a contribution of potentially toxic levels of the aminoacid homocysteine.
Detailed Description
We conducted a double blind , randomized, placebo controlled trial, for two years, enroling, simultaneously, 186 end-stage kidney disease patients of any cause, older than 18 years of age, stable on hemodialysis, assigned to receive either oral folic acid 10 mg three times a week on post dialysis sessions, under nurse supervision or an identical appearing placebo for the entire lenght of the study, from april 2003 to march 2005.
The two groups had similar baseline clinical and laboratory characteristics. There was no loss of follow-up. At admission, homocysteine serum levels were above 13,9 umol/L in 96.7% (median 25.0, range 9.3-104.0)with only five cases in the normal levels; homocysteine remained elevated at 6, 12 and 24 months on those receiving placebo; folate treatment significantly decreased total homocysteine levels to a median value of 10.5 umol/L (2.8 - 20.3)which remained at this level for the entire study time (P<0.001); every one was alive and tested at six months, sixty eight were either transplanted(15)or died (53) from cardiovascular disease(seventeen in the folic acid group and twenty one in the placebo (P>0.05)or other causes(15), after being included in the study. Intima-media wall thickness blinded measured at the common carotid artery decreased from 1.94+-0,59 mm to 1.67+-0.38 (P<0.001) with folate therapy and became thicker, from 1.86+-0.41 to 2.11+-0.48 mm in the placebo group.
In conclusion, folate treatment for two years was not effective on modifying cardiovascular death and non fatal cardiovascular events of this sample population with chronic uremia; however, the ultrasonographic evaluation of the common carotid arteries intima-media wall thickness at entry and twenty four months later unequivocally showed a significant thickness decrease with supervised folate intake.
Earlier prescription of folic acid might benefit patients with chronic renal failure,preventing cardiovascular deterioration
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremia, Chronic Renal Failure, Hemodialysis, Hyperhomocysteinemia, Cardiovascular Disease
Keywords
hemodialysis, chronic uremia, hyperhomocysteinemia, folate
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
186 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
folate treatment
Primary Outcome Measure Information:
Title
Lowering of Homocysteine blood levels in uremia.
Title
Prevention of cardiovascular events
Secondary Outcome Measure Information:
Title
Reduction of carotid intima-media thickness
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients stable on hemodialysis for 4 months or more
Eighteen years of age or older
Exclusion Criteria:
Potential kidney transplant from a living donor in the near future
Severe cardiovascular disease
Cancer and active inflammation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Altair J Mocelin, MD PHD
Organizational Affiliation
Nephrology, University Hospital, State University of Londrina
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario regional do Note do Parana
City
Londrina
State/Province
Parana
ZIP/Postal Code
86020-320
Country
Brazil
Facility Name
University Hospital, State University of Londrina
City
Londrina
State/Province
Parana
ZIP/Postal Code
86020-320
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
10456270
Citation
Brenner RM, Wrone EM. The epidemic of cardiovascular disease in end-stage renal disease. Curr Opin Nephrol Hypertens. 1999 May;8(3):365-9. doi: 10.1097/00041552-199905000-00015. No abstract available.
Results Reference
background
Learn more about this trial
Uremic Hyperhomocysteinemia -A Folate Trial for Possible Prevention of Cardiovascular Events
We'll reach out to this number within 24 hrs