Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217100
Status:
COMPLETED
Last Update Posted:
2012-04-25
First Post:
2005-09-20
Brief Title:
A Multivitamin Comparison Study in Kidney Transplant Recipients
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Folic Acid for Vascular Outcome Reduction in Transplantation
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None