Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114387
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2005-06-14
Brief Title:
VEAPS Vitamin E Atherosclerosis Prevention Study
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
VEAPS Vitamin E Atherosclerosis Prevention Study
Status:
COMPLETED
Status Verified Date:
2005-06
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 E DL-alpha-tocopherol supplementation will reduce the progression of early atherosclerosis in healthy individuals over 40 years of age with low-density lipoprotein LDL cholesterol levels greater than or equal to 130mgdL
Detailed Description:
The primary hypothesis to be tested is that vitamin E supplementation of 400 IUday exerts positive arterial wall effects by reducing progression of early atherosclerosis in healthy individuals 40 years old or older without clinical evidence of cardiovascular disease CVD Ultrasonography will be used to measure the rate of change of the distal common carotid artery CCA far wall intima-media thickness IMT The beneficial effects of vitamin E supplementation are expected to occur with or without a change in LDL-C levels
A total of 353 men and women will be recruited for the three-year trial Participants will be randomized into a treatment group to receive either vitamin E DL-alpha-tocopherol 400 IUday or a placebo The ultrasound measurement of CCA IMT will be repeated every six months for two years
A total of 353 men and women will be recruited for the three-year trial Participants will be randomized into a treatment group to receive either vitamin E DL-alpha-tocopherol 400 IUday or a placebo The ultrasound measurement of CCA IMT will be repeated every six months for two 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 |
|---|---|---|---|
| R01AG013860 | NIH | None | httpsreporternihgovquickSearchR01AG013860 |