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Prospective Study of Diet and Cardiovascular Disease

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005519
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: August 2004

May 25, 2000
June 23, 2005
September 1998
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Complete list of historical versions of study NCT00005519 on ClinicalTrials.gov Archive Site
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Prospective Study of Diet and Cardiovascular Disease
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To examine associations between various dietary elements and the risk of coronary heart disease and stroke.

BACKGROUND:

Cardiovascular disease is the leading cause of death among residents of the United States. The effect of dietary cholesterol and fat on risk of coronary heart disease (CHD) and stroke has been examined extensively in epidemiologic studies. However, the results from these studies are inconsistent. Furthermore, the association between some other key elements of diet and risk of CHD and stroke has been insufficiently studied in epidemiologic studies.

DESIGN NARRATIVE:

The study examines prospectively the association between: 1) dietary intake of trans-unsaturated fat and the risk of coronary heart disease and 2) dietary intake of total, saturated and unsaturated fats and risk of stroke; 3) dietary intake of vegetable and animal protein and risk of stroke; 4) dietary intake of total and water-soluble fiber and risk of coronary heart disease and stroke; 5) dietary intake of sodium and potassium and risk of coronary heart disease and stroke; 6) dietary intake of vitamin C, carotenoids, vitamin E, and folic acid and the risk of coronary heart disease and stroke; and 7) specific foods, such as fish, beans, fruits, and vegetables and the risk of coronary heart disease and stroke. In addition, the association of baseline serum vitamin A, vitamin C, and folate to the risk of coronary heart disease and stroke will be investigated.

Data from the NHANES1 Epidemiologic Follow-Up Study (NHEFS) will be used to test the hypotheses. The NHEFS is an on-going prospective cohort study being conducted in 14,407 United States men and women aged 25 to 74 years by the National Center for Health Statistics (NCHS). The baseline data, including a 24-hour dietary recall and food frequency questionnaire, as well as important cardiovascular risk factors were collected during 1971-75. The follow-up data were collected during 1982 to 1984, 1986, 1987, and 1992. The follow-up data were obtained by means of an interview, medical records from health care facilities, and death certificates for all decedents. In the study, the investigators will re-code dietary data and calculate dietary nutrients using the ESHA Nutrient Database. They will also analyze the relationship of dietary nutrients and specific foods to risk of CHD and stroke.

Observational
Observational Model: Defined Population
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  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
  • Cerebrovascular Accident
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2001
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No eligibility criteria

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00005519
5039
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Jiang He Tulane University
National Heart, Lung, and Blood Institute (NHLBI)
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP