FAVORIT Study

The Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) study is designed to determine if vitamin therapy to lower homocysteine

Homocysteine is an amino acid in the blood that is associated with a higher risk of cardiovascular disease. For more information on homocysteine, please visit www.medlineplus.gov or www.americanheart.org

levels reduces cardiovascular disease (CVD)CVD - Cardiovascular diseases include diseases of the heart and blood vessels (e.g., heart attack, stroke, and blood clots in the legs and arms). For more information on types of CVD, please visit www.medlineplus.gov or www.americanheart.org. in kidney transplant recipients. These diseases can cause outcomes such as chest pain, heart attack, poor circulation and stroke. Cardiovascular disease (CVD) is the leading cause of death among those with chronic renal (kidney) disease. Individuals with end stage renal disease have a 10 to 20 times greater risk of cardiovascular disease-related deaths than the general population. This increased risk may be due in part to a higher level of homocysteine in their blood. Homocysteine is made when your body uses protein for energy. Studies suggest that vitamin supplements of folic acid and vitamins B6 and B12 help to reduce any excess of homocysteine in the body. This study hopes to show that by reducing the level of homocysteine in the body, the risk of heart disease is also reduced among kidney transplant patients.

The Folic Acid for Vascular Outcome Reduction In Transplantation study is examining whether high does of folic acid, B6, and B12 reduce the number of CVD events in persons with kidney transplants. It is a multi-center trial, with 30 sites in the United States, Canada, and Brazil. Participants are randomly assigned to receive either a multivitamin with a high dose of folic acid, B6, and B12 or a multivitamin containing no folic acid, and Estimated Average Requirement amounts of B6 and B12. 4000 persons from the 30 transplant centers will be enrolled in the study. The study is double blind, meaning that neither the participants nor the investigators (e.g., clinic staff), know which type of vitamin a participant is assigned.

FAVORIT is sponsored by the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) at the National Institutes of Health.