Education and Training
Homocysteine Study (HOST)
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: PAL-40 Active
- drug: PAL-40 Placebo
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:
Ages Eligible for Study
21 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting