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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00554242 |
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Date of registration:
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05/11/2007 |
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Primary sponsor: |
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Public title:
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Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function
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Scientific title:
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Chronic Study of the Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function in Patients With Coronary Artery Disease |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00554242 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Joseph A Vita, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boston Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Coronary artery disease
Exclusion Criteria:
- Pregnancy
- Clinical history of other major illness including end-stage cancer, renal failure,
hepatic failure, gastrointestinal disorders that may impair absorption, or other
conditions that in the opinion of the principal investigator make a clinical study
inappropriate.
- Treatment with an investigational new drug within the last 30 days.
- History of a psychological illness or condition such as to interfere with the
subject's ability to understand the requirements of the study.
- Vitamin E, Vitamin C, and beta carotene, lipoic acid, and other food or herbal
supplements within 1 month of enrollment.
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Dietary Supplement: Grape seed extract and ascorbic acid
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Primary Outcome(s)
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Brachial artery flow-mediated dilation
[Time Frame: 1 month]
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Secondary Outcome(s)
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Carotid-femoral pulse wave velocity
[Time Frame: 1 month]
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Fingertip Pulse Amplitude Tonometry
[Time Frame: 1 month]
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Serum markers of inflammation
[Time Frame: 1 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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