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Homocysteine Study (HOST)

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ClinicalTrials.gov Identifier: NCT00032435
Recruitment Status : Completed
First Posted : March 22, 2002
Last Update Posted : October 15, 2010
Sponsor:
Collaborators:
Pan American Laboratories
Abbott Diagnostics Division
Information provided by:
VA Office of Research and Development

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
End Stage Renal Disease Renal Failure Drug: PAL-40 Active Drug: PAL-40 Placebo Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2003 participants
Masking: Double
Official Title: CSP #453 - Homocysteinemia in Kidney and Endstage Renal Disease Study (HOST)
Study Start Date : May 2001
Actual Primary Completion Date : August 2006
Actual Study Completion Date : September 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
PAL-40 Active
 Drug: PAL-40 Active
Placebo Comparator: 2
PAL-40 Placebo
 Drug: PAL-40 Placebo


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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
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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


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Sponsors and Collaborators
US Department of Veterans Affairs
Pan American Laboratories
Abbott Diagnostics Division
Investigators
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Study Chair: Rex L. Jamison VA Palo Alto Health Care System
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jamison, Rex - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032435     History of Changes
Other Study ID Numbers: 453
First Posted: March 22, 2002    Key Record Dates
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:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency