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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00005393 |
To measure serum concentrations of alpha tocopherol, selenium and all major carotenoids (alpha- and beta- carotene, lutein, (beta-cryptoxanthin and lycopene) in Black and white, male and female, high and low education individuals aged 18-30 in 1985-86.
Condition | Phase |
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Cardiovascular Diseases Heart Diseases Atherosclerosis Coronary Arteriosclerosis |
N/A |
Study Type: | Observational |
Study Start Date: | August 1996 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
BACKGROUND:
Low blood antioxidant concentrations are associated with several major degenerative diseases including cardiovascular disease and cancer.
Animal, cellular and chemical experiments have elucidated biologic mechanisms consistent with antioxidant protection against several disease processes.
Determinants of blood antioxidant concentrations are not well understood in young adults.
The main scientific outcome of this research will be information on distribution and correlates of blood antioxidant concentrations, useful for formulating public health messages concerning maintenance of adequate levels of alpha tocopherol, selenium, ascorbic acid and the carotenoids.
DESIGN NARRATIVE:
An analysis was conducted using serum stored at 70 degrees Celsius, collected in 1985-86 (n=5115) and 1992-93 (n=4086). These analytes were stable in serum samples collected, handled and stored under conditions used in this study. Integrity of the chemical analysis throughout the study was maintained by proven laboratory quality control procedures. Monitoring analyte concentrations in serum from collections seven years apart allowed analysis of age and time dependent changes in serum antioxidants. These data were linked with extensive pre-existing sociodemographic, dietary, other behavioral and physiologic data for the cohort. Statistical analyses provided information on the population's serum antioxidant distribution, tracking, change and major determinants in diverse young adults. In addition, these data established baseline and 7-year change concentration values for followup of this large CARDIA cohort, though the relationship of these serum antioxidants to disease endpoints was not itself part of the workscope. Study of plasma ascorbic acid, which is not stable under our storage conditions, was initiated using fresh samples to be collected in 1995-96 (n=4000).
The Young Adult Longitudinal Study of Antioxidants (YALTA), ancillary to CARDIA study, was renewed in FY 2000 to obtain additional blood and urine samples in the year 15 exam of the CARDIA participants. New measures of circulating lipid, protein, and DNA oxidation products (F2-isoprostanes, advanced glycosylation end-products [AGE], chlorinated and nitrosylated tyrosine, PAF acetylhydrolase, praroxonase), urinary DNA damage, soluble ICAM, soluble P-selectin, and relevant genetic polymorphisms. The specific endpoints at the 15 year exam were coronary artery calcification as measured by computed tomography and microalbuminuria.
The study was renewed in 2004 through 2008. Blood and urine will be collected from subjects at the CARDIA year 20 exam to remeasure blood F2 isoprostanes, phospholipase A2, superoxide dismutase and carotenoids and tocopherols. Oxidized LDL and myeloperoxidase will also be measured and analysis conducted of the association of antioxidant and oxidative damage levels and the development of subclinical macrovascular disease in this still-young group.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 4299 |
Study First Received: | May 25, 2000 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00005393 History of Changes |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Coronary Disease Atherosclerosis Heart Diseases Myocardial Ischemia |
Vascular Diseases Stress Ischemia Arteriosclerosis Coronary Artery Disease |
Coronary Disease Arterial Occlusive Diseases Atherosclerosis Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |