Conditions: Chronic Kidney Disease Cardiovascular Disease Death
Keywords: homocysteine multi-vitamin cardiovascular disease renal transplant recipients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4110
Healthy volunteers: no

Brief 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.

Detailed 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

Arms:
arm 1: Multivitamin with increased folic acid, vitamin B6 and vitamin B12 arm 2: Multivitamin devoid of folic acid and with estimated average requirement amounts of vitamin B6 and vitamin B12

Interventions: intervention 1: High Dose Multivitamin intervention 2: Low Dose Multivitamin
Intervention descriptions: intervention 1: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg intervention 2: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg

Protocol document: