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.
Participants will be seen for a screening visit where you will have physical measurements, blood pressure and a history taken. Blood and urine samples will be taken and be tested to see if you qualify for the study. The participant will continue to have their routine, yearly clinic visit with their transplant doctor for a physical, history, medication review and blood and urine samples.
A small portion of the blood and urine collected will be stored for future testing related only to the risk for cardiac kidney disease. Participants will also have a phone "visit" every 6 months for a short medical history. Participants will be asked to take the study medication provided.
Participants will be enrolled in this research study for up to 5 years.
Last updated: 04/23/2012
NCT ID: NCT00217100