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Homocysteine Study (HOST)
Not Recruiting
Trial ID: NCT00032435
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.
Official Title
CSP #453 - Homocysteinemia in Kidney and Endstage Renal Disease Study (HOST)
Stanford Investigator(s)
Eligibility
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:
Intervention(s):
drug: PAL-40 Active
drug: PAL-40 Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305