Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: Office of Dietary Supplements (ODS)
• Treatments: Folic Acid; Hydroxocobalamin; Pantothenic Acid; Pyridoxal; Pyridoxine; Vitamin B 12; Vitamin B 6; Vitamin B Complex; Vitamins

Criteria

Inclusion Criteria:

• 35 - 75 years old

• Had kidney transplant at least 6 months

• Calculated Creatinine Clearance must be 25 mL/min or greater

• Must be willing to stop supplements (B6, B12, folic acid) for 4-6 weeks prior to visit

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:

• Cancer

• Congestive heart failure (CHF) (end stage)

• Liver disease (end stage)

• Severe pulmonary disease

• Progressive HIV

• Any other chronic wasting illness

• 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