Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114400
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2005-06-14
Brief Title:
BVAIT B-Vitamin Atherosclerosis Intervention Trial
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
B-Vitamin Atherosclerosis Intervention Trial BVAIT
Status:
COMPLETED
Status Verified Date:
2007-02
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:
The purpose of this study is to examine whether vitamin B supplementation will reduce the progression of early atherosclerosis in individuals over 40 years old and without clinical evidence of cardiovascular disease CVD
Detailed Description:
The primary hypothesis to be tested is that daily vitamin B supplementation reduces progression of early atherosclerosis Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery and CT will be used to measure coronary and aortic calcium The beneficial effects of vitamin B supplementation are expected to occur with or without a change in LDL-C levels
A total of 506 men and women will be randomized to receive either 1 vitamin B supplementation consisting of folic acid 5mg vitamin B12 04mg and vitamin B6 50mg or 2 a matching placebo Participants will receive ultrasonography at baseline and every 6 months for 25 to 45 years and CT scan at baseline and end of study 25 to 45 years
A total of 506 men and women will be randomized to receive either 1 vitamin B supplementation consisting of folic acid 5mg vitamin B12 04mg and vitamin B6 50mg or 2 a matching placebo Participants will receive ultrasonography at baseline and every 6 months for 25 to 45 years and CT scan at baseline and end of study 25 to 45 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG017160 | NIH | None | httpsreporternihgovquickSearchR01AG017160 |