Uremic Hyperhomocysteinemia -A Folate Trial for Possible Prevention of Cardiovascular Events
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ClinicalTrials.gov Identifier: NCT00317005 |
Recruitment Status :
Completed
First Posted : April 21, 2006
Last Update Posted : July 26, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uremia Chronic Renal Failure Hemodialysis Hyperhomocysteinemia Cardiovascular Disease | Drug: folate treatment | Phase 4 |
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
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 186 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | April 2003 |
Study Completion Date : | March 2005 |

- Lowering of Homocysteine blood levels in uremia.
- Prevention of cardiovascular events
- Reduction of carotid intima-media thickness

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317005
Brazil | |
Hospital Universitario regional do Note do Parana | |
Londrina, Parana, Brazil, 86020-320 | |
University Hospital, State University of Londrina | |
Londrina, Parana, Brazil, 86020-320 |
Study Director: | Altair J Mocelin, MD PHD | Nephrology, University Hospital, State University of Londrina |
ClinicalTrials.gov Identifier: | NCT00317005 |
Other Study ID Numbers: |
UEL/CPG/Nefro/Hcy |
First Posted: | April 21, 2006 Key Record Dates |
Last Update Posted: | July 26, 2018 |
Last Verified: | May 2005 |
hemodialysis chronic uremia hyperhomocysteinemia folate |
Kidney Failure, Chronic Uremia Cardiovascular Diseases Hyperhomocysteinemia Renal Insufficiency Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic Amino Acid Metabolism, Inborn Errors |
Metabolism, Inborn Errors Genetic Diseases, Inborn Malabsorption Syndromes Metabolic Diseases Vitamin B Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |