Cardiovascular Diseases Clinical Trial
To describe and delineate in a prospective study the nature and causes of seasonal variation of blood lipid levels in the general population.
BACKGROUND:
Significant seasonal variation of blood cholesterol levels has been shown in a number of
cross-sectional studies, with important implications for national screening and therapeutic
guidelines. However, the phenomenon has not been well studied: little is known about
etiology or about seasonal variation of lipid subfractions.
DESIGN NARRATIVE:
The investigators assessed the magnitude and timing of the seasonal effect for total
cholesterol and the important lipoprotein subfractions (low-density lipoprotein,
high-density lipoprotein, triglycerides, apolipoproteins AI and B, and lipoprotein (a)) in
both sexes and at different ages. They also identified and quantified the effects of the
main factors determining the variation and assessed the seasonal variation of other blood
elements thought to play a role in the development of coronary heart disease, including
hemostatic factors and antioxidants Finally, they explored the implications of the
phenomenon for public health policy.
Baseline and serial measures were repeated quarterly for one year. These included measures
of: serum lipids and lipoproteins; antioxidant vitamins; platelets and hemostatic factors;
demographic factors; weight, waist-hip ratio, height, body mass index (BMI) and blood
pressure; dietary intake; physical activity; light exposure; and psychologic factors.
Meteorologic data were also collected. Data were collected by written questionnaire and by
the use of computer-assisted evening telephone interviews (CATI), which were used for the
collection of dietary, physical activity and individual light-exposure and other lifestyle
data. Activity and light data were verified in a subset of 80 patients by the use of a
monitoring device. Analyses included methods to describe the seasonal variation in dietary,
physical activity, psychologic, and light exposure data and repeated measures in linear
regression models to determine the roles of specific dietary, physical activity,
psychologic, and light-exposure related covariates in explaining variability in blood
lipids, antioxidant vitamins, and hemostatic factors.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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