A Multivitamin Comparison Study in Kidney Transplant Recipients.

Folic Acid for Vascular Outcome Reduction in Transplantation.

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant Recipients
• Intervention / Treatment: Dietary supplement: Multivitamin; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Sugar pill	Dietary supplement: Placebo; 1 tablet a day
ACTIVE_COMPARATOR: Multi Vitamin Formulation	Dietary supplement: Multivitamin; 1 tablet a day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: University of Alabama at Birmingham; University of Wisconsin, Madison; University of California, San Francisco; Ohio State University

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: September 20, 2005
• First Submitted That Met QC Criteria: September 20, 2005
• First Posted (ESTIMATE): September 22, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): April 25, 2012
• Last Update Submitted That Met QC Criteria: April 23, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 1965-04