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Seasonal Variation of Blood Cholesterol Levels
This study has been completed.
First Received: May 25, 2000   Last Updated: November 10, 2005   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005385
  Purpose

To describe and delineate in a prospective study the nature and causes of seasonal variation of blood lipid levels in the general population.


Condition
Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Coronary Disease

MedlinePlus related topics: Coronary Artery Disease Heart Diseases
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1994
Estimated Study Completion Date: July 1999
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005385

Sponsors and Collaborators
Investigators
Investigator: Ira Ockene University of Massachusetts Medical School
  More Information

Publications:
Study ID Numbers: 4290
Study First Received: May 25, 2000
Last Updated: November 10, 2005
ClinicalTrials.gov Identifier: NCT00005385     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009