NCT00217100

A Multivitamin Comparison Study in Kidney Transplant Recipients.

Folic Acid for Vascular Outcome Reduction in Transplantation.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Kidney Transplant Recipients

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Multivitamin	1 tablet a day
DIETARY_SUPPLEMENT	Placebo	1 tablet a day

Timeline

• Start date: 2004-10-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2005-09-22
• Last updated: 2012-04-25

Locations

1 site across 1 country: United States