Homocysteine Study (HOST)

This study has been completed.
Sponsor:
Collaborators:
Pan American Laboratories
Abbott Diagnostics Division
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032435
First received: March 20, 2002
Last updated: October 14, 2010
Last verified: October 2010
  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:


Further study details as provided by Department of Veterans Affairs:

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

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

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Department of Veterans Affairs:
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 April 15, 2014