Health Professionals Follow-up Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eric B. Rimm, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00005182
First received: May 25, 2000
Last updated: March 19, 2013
Last verified: March 2013

May 25, 2000
March 19, 2013
December 1985
May 2008   (final data collection date for primary outcome measure)
Incident CVD [ Time Frame: Renewed every 5 years since 1986 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00005182 on ClinicalTrials.gov Archive Site
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Health Professionals Follow-up Study
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To test the hypothesis that increased risk of coronary heart disease, stroke, peripheral vascular disease, and cancer is related to diets high in saturated fat, animal protein, and hydrogenated vegetable oil, and low in polyunsaturated fat, fiber, vitamins A, C, and E, calcium, selenium, and chromium.

BACKGROUND:

The diet-heart hypothesis, that high dietary saturated fat and cholesterol intake increase the risk and high polyunsaturated fat reduces the risk of coronary heart disease in man is supported by ecologic studies, by experiments in rodents and non-human primates, by voluminous literature relating dietary factors to serum lipids, by several secondary prevention trials, and by the Lipid Research Clinics Trial demonstrating a reduction in coronary heart disease among participants assigned to cholestyramine.

Despite the substantial scientific interest and the obvious public health implications of the diet and heart disease issue, relatively few observational cohort or case-control investigations had been published prior to 1985. Although these observational studies were not entirely consistent, taken collectively, they tended to provide important general support for the diet-heart hypothesis. However, due to study design, limited numbers of endpoints, or methods of analysis, many central questions remained unanswered. The most important issue was the quantitative relationship between specific dietary factors and risk of coronary heart disease.

DESIGN NARRATIVE:

In this prospective cohort study, participants completed a mailed general medical and health questionnaire at baseline and an intensively validated semiquantitative food frequency questionnaire (SFFQ). At one year, tissue specimens were collected and catalogued for future nested case-control analyses of coronary heart disease risk in relation to levels of calcium, selenium, and chromium. Follow-up questionnaires to update exposure information and ascertain non-fatal endpoints were mailed at two-year intervals. All reported cases of non-fatal myocardial infarction, stroke, and cancer were documented with hospital records and/or pathology reports. Fatal events were ascertained with the National Death Index and documented. To standardize SFFQ nutrient scores against measurements of absolute intake, two one-week diet records were obtained from a random sample of 150 Boston-area participants.

The study was renewed in 1991, 1997, and in 2003 to continue the follow-up of 51,529 male health professionals. The cohort is followed by questionnaires mailed at two-year intervals to update exposure information and ascertain nonfatal events. Complete dietary assessments are included every four years.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

plasma, RBC, WBC

Non-Probability Sample

Male Health Professionals

  • Cardiovascular Diseases
  • Cerebrovascular Accident
  • Coronary Disease
  • Peripheral Vascular Diseases
  • Heart Diseases
  • Myocardial Infarction
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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
50000
May 2008
May 2008   (final data collection date for primary outcome measure)

Recruited through their professional organizations or occupation from mailing house lists.

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00005182
1060, R00HL088372
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Eric B. Rimm, Harvard School of Public Health
Harvard School of Public Health
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Eric Rimm Harvard School of Public Health
Harvard School of Public Health
March 2013

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