A Multivitamin Comparison Study in Kidney Transplant Recipients.
A Multivitamin Comparison Study in Kidney Transplant Recipients.
This study is being done to compare arteriosclerotic cardiovascular disease in kidney
 transplant recipient taking a standard multivitamin versus those taking a multivitamin
 augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6.
This is a multicenter, randomized, double-blind controlled clinical trial. The trial has been
 designed to determine whether total homocysteine lowering treatment with a standard
 multivitamin augmented by a multivitamin containing no folic acid B12, and vitamin B6, versus
 treatment with an identical multivitamin containing no folic acid, will reduce the pooled
 rate of recurrent or new cardiovascular disease outcomes or events. Participants will have a
 brief visit, at which the participant will have physical measurements, blood pressure and
 history taken. Urine and blood tests will be performed to determine the levels of
 homocysteine, vitamins and creatinine. Qualifying participants will be randomly assigned to
 receive multivitamins containing a high dose of folic acid, vitamin B6, and vitamin B12, or
 an identical multivitamin containing no folic acid, and estimated average requirement amounts
 of vitamin B6 and vitamin B12. The participant will be required to return annually throughout
 the next five years for physical exams, blood and urine tests.
Participants with elevated homocysteine levels that are between the ages of 35-75 years old
 and have had a kidney transplant with stable renal graft function.