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Sacramento, California

  • Cardiovascular Diseases

Purpose:

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


Study summary:

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.


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.


Study is Available At:


Original ID:

R01 AT000005-02


NCT ID:

NCT00010699


Secondary ID:


Study Acronym:


Brief Title:

Effect of High Dose Vitamin E on Carotid Atherosclerosis


Official Title:

Effect of High Dose Vitamin E on Carotid Atherosclerosis


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Center for Complementary and Alternative Medicine (NCCAM)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Masking: Double-Blind, P


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:


Overall Contact Information

Official Name:Ishwarlal Jialal, MD, Ph.D.
Principal Investigator
Department of Pathology

Study Dates

Completion Date:April 2003
Completion Type:Actual
Primary Completion Date:April 2003
Primary Completion Type:Actual
Verification Date:March 2013
Last Changed Date:March 21, 2013
First Received Date:February 2, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Vitamin E

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:Office of Dietary Supplements (ODS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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