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| Sponsored by: |
Universidade Estadual de Londrina |
|---|---|
| Information provided by: | Universidade Estadual de Londrina |
| ClinicalTrials.gov Identifier: | NCT00317005 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomized Clinical Trial of Folate Therapy/Placebo for Reduction of Homocysteine Serum Levels in Uremic Patients and Influence on Cardiovascular Mortality |
| Estimated Enrollment: | 186 |
| Study Start Date: | April 2003 |
| Estimated Study Completion Date: | March 2005 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Brazil, Parana | |
| University Hospital, State University of Londrina | |
| Londrina, Parana, Brazil, 86020-320 | |
| Hospital Universitario regional do Note do Parana | |
| Londrina, Parana, Brazil, 86020-320 | |
| Study Director: | Altair J Mocelin, MD PHD | Nephrology, University Hospital, State University of Londrina |
More Information
| Study ID Numbers: | UEL/CPG/Nefro/Hcy |
| Study First Received: | April 18, 2006 |
| Last Updated: | April 20, 2006 |
| ClinicalTrials.gov Identifier: | NCT00317005 History of Changes |
| Health Authority: | Brazil: Ministry of Health |
|
hemodialysis chronic uremia hyperhomocysteinemia folate |
|
Renal Insufficiency Vitamin B Complex Metabolic Diseases Hyperhomocysteinemia Hematinics Amino Acid Metabolism, Inborn Errors Kidney Failure, Chronic Folate Trace Elements Folinic Acid Vitamin B9 Folic Acid |
Metabolism, Inborn Errors Urologic Diseases Genetic Diseases, Inborn Renal Insufficiency, Chronic Inborn Amino Acid Metabolism Disorder Vitamins Uremia Micronutrients Kidney Diseases Metabolic Disorder Kidney Failure |
|
Renal Insufficiency Vitamin B Complex Metabolic Diseases Hyperhomocysteinemia Hematinics Amino Acid Metabolism, Inborn Errors Growth Substances Hematologic Agents Physiological Effects of Drugs Kidney Failure, Chronic Pharmacologic Actions Folic Acid |
Metabolism, Inborn Errors Urologic Diseases Genetic Diseases, Inborn Renal Insufficiency, Chronic Therapeutic Uses Vitamins Uremia Cardiovascular Diseases Micronutrients Kidney Diseases Kidney Failure |
