A Multivitamin Comparison Study in Kidney Transplant Recipients.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Folic Acid for Vascular Outcome Reduction in Transplantation.

Conditions
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Kidney Transplant Recipients

Intervention / Treatment
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* Dietary Supplement: Multivitamin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multi Vitamin Formulation<br> | Dietary Supplement: Multivitamin<br>* 1 tablet a day<br>|
| Placebo Comparator: Sugar pill<br> | Dietary Supplement: Placebo<br>* 1 tablet a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Average Requirement (EAR) amounts | to determine whether total homocysteine (tHcy)-lowering treatment with a standard multivitamin augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6, versus treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement (EAR) amounts of vitamin B6 and vitamin B12., reduces the pooled rate of recurrent and de novo cardiovascular disease [CVD]outcomes | basline to death or common end date 4.5 years |