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Pooling of Cohort Studies on Diet & Coronary Disease

Primary Purpose

Coronary Arteriosclerosis, Cardiovascular Diseases, Heart Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Coronary Arteriosclerosis

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 28, 2000
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006309
    Brief Title
    Pooling of Cohort Studies on Diet & Coronary Disease
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    December 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To quantify the role of dietary factors in the etiology of coronary heart disease by pooling data from 10 major prospective studies on diet and coronary heart disease.
    Detailed Description
    DESIGN NARRATIVE: Specific hypotheses tested included an adverse effect of saturated fat and carotenoids (alpha-carotene, lutein, and lycopene), flavonoids, folic acid, and vitamin B6. Plausible biological interactions between nutrients, such as fatty acids of the n-6 and n-3 series were also explored. Each participating center sent data on tape to the coordinating unit at the Department of Nutrition, Harvard School of Public Health. The relations of dietary factors and coronary heart disease were first estimated within each study and compared for consistency. Data were then combined to obtain the best overall estimates, taking into account the validity of dietary data collected at each center. Members from study centers met annually to discuss the interpretation of findings. Over 6,000 cases of myocardial infarction or coronary death were anticipated, which should have provided excellent precision in measuring associations, and allowed the comparison of extreme intakes that were poorly represented in individual studies. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Arteriosclerosis, Cardiovascular Diseases, Heart Diseases

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alberto Ascherio
    Organizational Affiliation
    Harvard Medical School (HMS and HSDM)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14980987
    Citation
    Pereira MA, O'Reilly E, Augustsson K, Fraser GE, Goldbourt U, Heitmann BL, Hallmans G, Knekt P, Liu S, Pietinen P, Spiegelman D, Stevens J, Virtamo J, Willett WC, Ascherio A. Dietary fiber and risk of coronary heart disease: a pooled analysis of cohort studies. Arch Intern Med. 2004 Feb 23;164(4):370-6. doi: 10.1001/archinte.164.4.370.
    Results Reference
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    PubMed Identifier
    15585762
    Citation
    Knekt P, Ritz J, Pereira MA, O'Reilly EJ, Augustsson K, Fraser GE, Goldbourt U, Heitmann BL, Hallmans G, Liu S, Pietinen P, Spiegelman D, Stevens J, Virtamo J, Willett WC, Rimm EB, Ascherio A. Antioxidant vitamins and coronary heart disease risk: a pooled analysis of 9 cohorts. Am J Clin Nutr. 2004 Dec;80(6):1508-20. doi: 10.1093/ajcn/80.6.1508.
    Results Reference
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    Pooling of Cohort Studies on Diet & Coronary Disease

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