Uremic Hyperhomocysteinemia -A Folate Trial for Possible Prevention of Cardiovascular Events

This study has been completed.
Sponsor:
Information provided by:
Universidade Estadual de Londrina
ClinicalTrials.gov Identifier:
NCT00317005
First received: April 18, 2006
Last updated: April 20, 2006
Last verified: May 2005
  Purpose

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.


Condition Intervention Phase
Uremia
Chronic Renal Failure
Hemodialysis
Hyperhomocysteinemia
Cardiovascular Disease
Drug: folate treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial of Folate Therapy/Placebo for Reduction of Homocysteine Serum Levels in Uremic Patients and Influence on Cardiovascular Mortality

Resource links provided by NLM:


Further study details as provided by Universidade Estadual de Londrina:

Primary Outcome Measures:
  • Lowering of Homocysteine blood levels in uremia.
  • Prevention of cardiovascular events

Secondary Outcome Measures:
  • Reduction of carotid intima-media thickness

Estimated Enrollment: 186
Study Start Date: April 2003
Estimated Study Completion Date: March 2005
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00317005

Locations
Brazil
University Hospital, State University of Londrina
Londrina, Parana, Brazil, 86020-320
Hospital Universitario regional do Note do Parana
Londrina, Parana, Brazil, 86020-320
Sponsors and Collaborators
Universidade Estadual de Londrina
Investigators
Study Director: Altair J Mocelin, MD PHD Nephrology, University Hospital, State University of Londrina
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00317005     History of Changes
Other Study ID Numbers: UEL/CPG/Nefro/Hcy
Study First Received: April 18, 2006
Last Updated: April 20, 2006
Health Authority: Brazil: Ministry of Health

Keywords provided by Universidade Estadual de Londrina:
hemodialysis
chronic uremia
hyperhomocysteinemia
folate

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Failure, Chronic
Renal Insufficiency
Uremia
Hyperhomocysteinemia
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Folic Acid
Vitamin B Complex
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014