Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064753
Status:
COMPLETED
Last Update Posted:
2017-10-18
First Post:
2003-07-11
Brief Title:
Folic Acid for Vascular Outcome Reduction In Transplantation FAVORIT
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Folic Acid for Vascular Outcome Reduction In Transplantation FAVORIT
Status:
COMPLETED
Status Verified Date:
2015-10
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:
FAVORIT
Brief Summary:
The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes
Detailed Description:
The hypothesis of the trial is as follows Treatment with a high dose combination of folic acid vitamin B6 and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes ie pooled occurrence of non-fatal and fatal arteriosclerotic outcomes including coronary heart cerebrovascular and peripheral vascular disease events relative to treatment with an identical multivitamin containing no folic acid and Estimated Average Requirement amounts of vitamin B6 vitamin B12 among chronic stable renal transplant recipients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DK061700 | NIH | None | httpsreporternihgovquickSearchU01DK061700 |