Effect of High Dose Vitamin E on Carotid Atherosclerosis
Primary Purpose
Cardiovascular Diseases
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin E
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring cvd
Eligibility Criteria
Inclusion Criteria: Must be on the American Heart Association Phase II diet and a HMG CoA reductase inhibitor for at least one year Have an LDL cholesterol <125 mg/dL on 2 visits at least 4 weeks apart during the 10 month lead in phase.
Sites / Locations
- UC Davis Medical Center
- University of California Davis Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00010699
First Posted
February 2, 2001
Last Updated
March 21, 2013
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
1. Study Identification
Unique Protocol Identification Number
NCT00010699
Brief Title
Effect of High Dose Vitamin E on Carotid Atherosclerosis
Official Title
Effect of High Dose Vitamin E on Carotid Atherosclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
4. Oversight
5. Study Description
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 IU/day 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 mg/dL 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, 1.5 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases
Keywords
cvd
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vitamin E
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be on the American Heart Association Phase II diet and a HMG CoA reductase inhibitor for at least one year
Have an LDL cholesterol <125 mg/dL on 2 visits at least 4 weeks apart during the 10 month lead in phase.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ishwarlal Jialal, MD, Ph.D.
Organizational Affiliation
Department of Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
Country
United States
12. IPD Sharing Statement
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Effect of High Dose Vitamin E on Carotid Atherosclerosis
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