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About
The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.
Full description
The hypothesis of the trial is as follows: Treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular disease events) relative to treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12, among chronic, stable renal transplant recipients
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
If pregnant or lactating
If of child bearing potential and not on birth control
If any of the following will limit life expectancy to less than 2 yrs:
If patient had myocardial infarction (MI), stroke, lower extremity amputation above ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower extremity) in past 2months
If patient had coronary artery bypass graft (CABG) or abdominal aortic aneurysm (AAA) in past 5 months
If patient has conditions that prevent reliable study participation e.g., depression, alcohol or drug abuse, other cardiovascular disease (CVD) studies
If patient has had multi-organ transplant, except kidney/pancreas
Primary purpose
Allocation
Interventional model
Masking
4,110 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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