Homocysteine Study (HOST)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00032435

First Posted: March 22, 2002

Last Update Posted: October 15, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Pan American Laboratories

Abbott Diagnostics Division

Information provided by:

VA Office of Research and Development

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
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

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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): 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
First Submitted:	March 20, 2002
First Posted:	March 22, 2002
Last Update Posted:	October 15, 2010
Last Verified:	October 2010

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

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