A Multivitamin Comparison Study in Kidney Transplant Recipients.

Folic Acid for Vascular Outcome Reduction in Transplantation.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00217100

Enrollment

200

Registered

2005-09-22

Start date

2004-10-31

Completion date

2010-02-28

Last updated

2012-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Recipients

Brief 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.

Interventions

DIETARY_SUPPLEMENTMultivitamin

1 tablet a day

DIETARY_SUPPLEMENTPlacebo

1 tablet a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
Estimated Average Requirement (EAR) amounts	basline to death or common end date 4.5 years	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026