Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010699
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2001-02-02
Brief Title:
Effect of High Dose Vitamin E on Carotid Atherosclerosis
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Effect of High Dose Vitamin E on Carotid Atherosclerosis
Status:
COMPLETED
Status Verified Date:
2013-03
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 primary aim of the present study is to test the effect of alpha-tocopherol supplementation on the progression of carotid atherosclerosis in patients with coronary artery disease
Detailed Description:
Cardiovascular disease is the leading cause of morbidity and mortality in Westernized populations Oxidation of low-density lipoprotein LDL appears to be a crucial step in atherogenesis Thus the role of dietary micronutrients in decreasing LDL oxidation assumes considerable significance The most consistent data with respect to micronutrient antioxidants and atherosclerosis appear to relate to a-tocopherol AT the predominant lipid-soluble antioxidant in LDL In addition to decreasing LDL oxidation data support an effect of AT on critical cells in atherogenesis monocytes smooth muscle cells and endothelium that are potentially anti-atherogenic
The primary aim of the present study is to test the effect of AT supplementation 1200 IUday of RRR-AT in a placebo-controlled randomized double blind trial over 2 years on the progression of carotid atherosclerosis in patients with coronary artery disease stable angina pectoris or previous myocardial infarction
Subjects recruited would have to be on the American Heart Association Phase II diet and a HMG CoA reductase inhibitor for at least one year and have an LDL cholesterol 125 mgdL on 2 visits at least 4 weeks apart during the 10 month lead in phase Intimal-medial thickness IMT of both carotids including the common carotid the bulb and the proximal internal carotid will be determined by high-resolution B-mode sonography At six month intervals blood samples will be obtained for liver enzymes creatinine complete blood count lipid profile antioxidant and fatty acid levels LDL oxidation plasma soluble CAMS cell adhesion molecules and monocyte activity Also an early morning urine sample will be obtained for F2 -isoprostanes a direct measure of lipid peroxidation IMT will be determined at baseline 1 15 and 2 years The mean change in IMT and rate of progression will be compared between the AT and placebo groups Following isolation the LDL will be subjected to copper catalyzed oxidation over a 5-hour period From this will be obtained the lag phase and oxidation rate Isolated monocytes will be activated with lipopolysaccharide and the following activities assayed superoxide anion release interleukin-1 j3 release and adhesion to human endothelium F2 isoprostanes and VCAM ICAM and E- 8 P-Selectin will be quantitated by ELISA AT levels and the parameters of LDL oxidation and monocyte activity will be correlated with changes in IMT
If this study shows that high-dose AT supplementation is beneficial in retarding atherosclerosis this could emerge as an important adjunctive therapy in the management of cardiovascular disease
The primary aim of the present study is to test the effect of AT supplementation 1200 IUday of RRR-AT in a placebo-controlled randomized double blind trial over 2 years on the progression of carotid atherosclerosis in patients with coronary artery disease stable angina pectoris or previous myocardial infarction
Subjects recruited would have to be on the American Heart Association Phase II diet and a HMG CoA reductase inhibitor for at least one year and have an LDL cholesterol 125 mgdL on 2 visits at least 4 weeks apart during the 10 month lead in phase Intimal-medial thickness IMT of both carotids including the common carotid the bulb and the proximal internal carotid will be determined by high-resolution B-mode sonography At six month intervals blood samples will be obtained for liver enzymes creatinine complete blood count lipid profile antioxidant and fatty acid levels LDL oxidation plasma soluble CAMS cell adhesion molecules and monocyte activity Also an early morning urine sample will be obtained for F2 -isoprostanes a direct measure of lipid peroxidation IMT will be determined at baseline 1 15 and 2 years The mean change in IMT and rate of progression will be compared between the AT and placebo groups Following isolation the LDL will be subjected to copper catalyzed oxidation over a 5-hour period From this will be obtained the lag phase and oxidation rate Isolated monocytes will be activated with lipopolysaccharide and the following activities assayed superoxide anion release interleukin-1 j3 release and adhesion to human endothelium F2 isoprostanes and VCAM ICAM and E- 8 P-Selectin will be quantitated by ELISA AT levels and the parameters of LDL oxidation and monocyte activity will be correlated with changes in IMT
If this study shows that high-dose AT supplementation is beneficial in retarding atherosclerosis this could emerge as an important adjunctive therapy in the management of cardiovascular disease
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