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Homocysteine Study (HOST)

This study has been completed.
Pan American Laboratories
Abbott Diagnostics Division
Information provided by:
VA Office of Research and Development Identifier:
First received: March 20, 2002
Last updated: October 14, 2010
Last verified: October 2010
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:

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

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 identifier: NCT00032435

  Show 37 Study Locations
Sponsors and Collaborators
VA Office of Research and Development
Pan American Laboratories
Abbott Diagnostics Division
Study Chair: Rex L. Jamison VA Palo Alto Health Care System
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jamison, Rex - Study Chair, Department of Veterans Affairs Identifier: NCT00032435     History of Changes
Other Study ID Numbers: 453
Study First Received: March 20, 2002
Last Updated: October 14, 2010

Keywords provided by VA Office of Research and Development:
vitamin B6

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic processed this record on September 18, 2017