Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000600
Status:
TERMINATED
Last Update Posted:
2013-12-13
First Post:
1999-10-27
Brief Title:
Vitamin E and C to Slow Progression of Common Carotid Artery Plaque Build-Up
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Antioxidants and Prevention of Early Atherosclerosis
Status:
TERMINATED
Status Verified Date:
2006-10
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:
None
Brief Summary:
This study will evaluate the effects of vitamin E supplementation in retarding the progression of common carotid artery intima-media thickening in African Americans
Detailed Description:
BACKGROUND
Evidence from epidemiologic studies and from one unpublished study suggests that greater intake of antioxidant vitamins is associated with reduced risk of coronary heart disease and stroke Findings from an animal model indicate that increased intake of antioxidant vitamins prevents progression of aortic fatty streaks induced by an atherogenic diet but not from more advanced injury-induced lesions These observations suggest the hypothesis that increased antioxidant vitamin intake may prevent further progression of early atherosclerosis possibly by means of reduced susceptibility of low density lipoprotein to oxidative modification and consequent cytotoxic chemotactic chemostatic and unregulated uptake effects
A new automated low-cost portable ultrasound system for determining intima-media thickness of the common carotid artery makes it feasible to test the primary prevention impact of antioxidant vitamins on early atherosclerosis Results of two studies at the University of Southern California suggest that the low-density lipoprotein effects on common carotid artery intima-media thickness can be detected by automated methods within 12 to 24 months in small patient samples Retardation of intima-media thickness progression was achieved in both studies without significant changes in average vessel diameter which suggests effects on early atherosclerotic lesions
DESIGN NARRATIVE
Patients will be screened for carotid intima-media thickness at home or at schools in mobile vans equipped with portable ultrasound equipment After 12 months those patients above the age and sex-adjusted 66th percentile at Screen I will be re-screened Screen II and those showing the greatest progression in intima-media thickness will be invited to participate in a trial run-in to assess vitamin E compliance Patients will be randomized to the following four groups 1 vitamin E 573 mgday 2 vitamin C 3 Vitamin E and C combined and 4 placebo Common carotid artery intima-media thickness will be observed by ultrasound at 12- and 24-month follow-ups The primary outcome is 24-month rate of change in average common carotid artery intima-media thickness
The study completion date listed in this record was obtained from the QueryViewReport QVR System
Evidence from epidemiologic studies and from one unpublished study suggests that greater intake of antioxidant vitamins is associated with reduced risk of coronary heart disease and stroke Findings from an animal model indicate that increased intake of antioxidant vitamins prevents progression of aortic fatty streaks induced by an atherogenic diet but not from more advanced injury-induced lesions These observations suggest the hypothesis that increased antioxidant vitamin intake may prevent further progression of early atherosclerosis possibly by means of reduced susceptibility of low density lipoprotein to oxidative modification and consequent cytotoxic chemotactic chemostatic and unregulated uptake effects
A new automated low-cost portable ultrasound system for determining intima-media thickness of the common carotid artery makes it feasible to test the primary prevention impact of antioxidant vitamins on early atherosclerosis Results of two studies at the University of Southern California suggest that the low-density lipoprotein effects on common carotid artery intima-media thickness can be detected by automated methods within 12 to 24 months in small patient samples Retardation of intima-media thickness progression was achieved in both studies without significant changes in average vessel diameter which suggests effects on early atherosclerotic lesions
DESIGN NARRATIVE
Patients will be screened for carotid intima-media thickness at home or at schools in mobile vans equipped with portable ultrasound equipment After 12 months those patients above the age and sex-adjusted 66th percentile at Screen I will be re-screened Screen II and those showing the greatest progression in intima-media thickness will be invited to participate in a trial run-in to assess vitamin E compliance Patients will be randomized to the following four groups 1 vitamin E 573 mgday 2 vitamin C 3 Vitamin E and C combined and 4 placebo Common carotid artery intima-media thickness will be observed by ultrasound at 12- and 24-month follow-ups The primary outcome is 24-month rate of change in average common carotid artery intima-media thickness
The study completion date listed in this record was obtained from the QueryViewReport QVR System
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 |
|---|---|---|---|
| U01HL052073 | NIH | None | httpsreporternihgovquickSearchU01HL052073 |