Homocysteine Study (HOST)

This study has been completed.

Sponsor:

Collaborators:

Pan American Laboratories

Abbott Diagnostics Division

Information provided by:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT00032435

First received: March 20, 2002

Last updated: October 14, 2010

Last verified: October 2010

History of Changes

Purpose

The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and the death rate compared to patients who receive placebo. The secondary objective is to test the hypothesis that intake of the vitamins compared to placebo decreases the incidence of myocardial infarction, disabling stroke, and amputation of a lower extremity and, in hemodialysis patients, thrombosis of the vascular access.

Condition	Intervention	Phase
End Stage Renal Disease Renal Failure	Drug: PAL-40 Active Drug: PAL-40 Placebo	Phase 3


Study Type:	Interventional
Study Design:	Masking: Double-Blind
Official Title:	CSP #453 - Homocysteinemia in Kidney and Endstage Renal Disease Study (HOST)

Resource links provided by NLM:

MedlinePlus related topics: Kidney Diseases Kidney Failure

U.S. FDA Resources

Further study details as provided by VA Office of Research and Development:


Estimated Enrollment:	2003
Study Start Date:	May 2001
Study Completion Date:	September 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 PAL-40 Active	Drug: PAL-40 Active
Placebo Comparator: 2 PAL-40 Placebo	Drug: PAL-40 Placebo

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Eligibility


Ages Eligible for Study:	21 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients will be screened by their plasma homocysteine concentration. They must have a level of at least 15 mM/L to be enrolled in the study.

Patients will be excluded by any of the following criteria: age less than 21 years, expected life span less than 6 months, pregnancy, metastatic cancer, end-stage liver disease, treatment with methotrexate, other anti-folate medication or anticonvulsants, unreliable or likely noncompliant, participation in another long-term trial, or unwilling or unable to give informed consent.

Exclusion Criteria:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032435

Show 37 Study Locations

Sponsors and Collaborators

VA Office of Research and Development

Pan American Laboratories

Abbott Diagnostics Division

Investigators


Study Chair:	Rex L. Jamison	VA Palo Alto Health Care System

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brady CB, Gaziano JM, Cxypoliski RA, Guarino PD, Kaufman JS, Warren SR, Hartigan P, Goldfarb DS, Jamison RL. Homocysteine lowering and cognition in CKD: the Veterans Affairs homocysteine study. Am J Kidney Dis. 2009 Sep;54(3):440-9. doi: 10.1053/j.ajkd.2009.05.013. Epub 2009 Jul 23.

Jamison RL, Shih MC, Humphries DE, Guarino PD, Kaufman JS, Goldfarb DS, Warren SR, Gaziano JM, Lavori P; Veterans Affairs Site Investigators. Effect of the MTHFR C677T and A1298C polymorphisms on survival in patients with advanced CKD and ESRD: a prospective study. Am J Kidney Dis. 2009 May;53(5):779-89. doi: 10.1053/j.ajkd.2008.12.023. Epub 2009 Mar 9.

Jamison RL, Hartigan P, Kaufman JS, Goldfarb DS, Warren SR, Guarino PD, Gaziano JM; Veterans Affairs Site Investigators. Effect of homocysteine lowering on mortality and vascular disease in advanced chronic kidney disease and end-stage renal disease: a randomized controlled trial. JAMA. 2007 Sep 12;298(10):1163-70. Erratum in: JAMA. 2008 Jul 9;300(2):170.


Responsible Party:	Jamison, Rex - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00032435 History of Changes
Other Study ID Numbers:	453
Study First Received:	March 20, 2002
Last Updated:	October 14, 2010
Health Authority:	United States: Federal Government United States: Food and Drug Administration

Keywords provided by VA Office of Research and Development:


folate pyridoxine vitamin B6 cyanocobalamin homoc

Additional relevant MeSH terms:


Kidney Diseases Kidney Failure, Chronic Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 28, 2016

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