Clinical Trials Directory

Trials / Completed

CompletedNCT00006309

Pooling of Cohort Studies on Diet & Coronary Disease

Status
Completed
Phase
Study type
Observational
Enrollment
Sponsor
National Heart, Lung, and Blood Institute (NHLBI) · NIH
Sex
Male
Age
100 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
1999-09-01
Completion
2002-08-01
First posted
2000-09-29
Last updated
2016-02-18

Source: ClinicalTrials.gov record NCT00006309. Inclusion in this directory is not an endorsement.