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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03218020
Other study ID # DKFZ Study_ID 905
Secondary ID
Status Completed
Phase N/A
First received July 13, 2017
Last updated July 14, 2017
Start date September 1, 1994
Est. completion date December 31, 2009

Study information

Verified date July 2017
Source German Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Increased iron load could be a risk factor for cardiovascular diseases (CVD). Red meat consumption affects iron status and has also been shown to be related to increased CVD risk. The investigators hypothesized that risk associations between red meat intake and cardiovascular disease risk can to some degree be explained by higher iron load among individuals with higher meat intake. Thus, the investigators evaluate associations between red meat consumption, iron status, and CVD risk in a large-scale population based study, the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg.


Description:

The present study part of the the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg, a large-scale observational cohort study located at the German Cancer Research Center, Heidelberg, Germany. The study started between 1994 and 1998, when 25 540 adults from the local general population were recruited. Study participants are being followed-up by active and passive procedures. The main aim of the study is to evaluate associations between diet, lifestyle as well as metabolism and risks of major chronic diseases (cancer, cardiovascular diseases, diabetes).

Here, the investigators register a project from within EPIC-Heidelberg on prediagnostic iron status as a potential mediator of associations between pre-diagnostic red meat consumption and cardiovascular disease risk. For this particular project, an embedded case-cohort set-up was chosen, i.e. iron status markers (primary marker: serum ferritin; secondary markers: serum transferrin, serum iron) were measured in baseline blood samples from a random subcohort (n=2738) and all validated incident cases of myocardial infarction (n=556), stroke (n=513), and CVD death (n=327) that occured until the closure date of the present study (12-31-2009).

Statistical analyses follow four steps to assess whether iron status may mediate associations between red meat consumption and CVD risk, as proposed by Wittenbecher et al. (Am J Clin Nutr, 2015: www.ncbi.nlm.nih.gov/pubmed/25948672):

1. Multivariable Cox regression analyses on red meat consumption and CVD risk, assuming a significant positive association

2. Multivariable linear regression analyses on red meat consumption and iron status, assuming a significant positive association

3. Multivariable Cox regression analyses on iron status and CVD risk, assuming a significant positive association

4. Multivariable Cox regression analyses on red meat consumption and CVD risk, additionally adjusting for iron status, assuming that the association will be attenuated by adjustment for iron status


Recruitment information / eligibility

Status Completed
Enrollment 25540
Est. completion date December 31, 2009
Est. primary completion date December 31, 2009
Accepts healthy volunteers
Gender All
Age group 35 Years to 65 Years
Eligibility Inclusion Criteria:

General population, age 35-65 years

Exclusion Criteria:

Prevalent myocardial infraction or stroke

Study Design


Intervention

Other:
No intervention assigned, this is an observational study.
No intervention assigned, this is an observational study.

Locations

Country Name City State
Germany German Cancer Research Center Heidelberg

Sponsors (1)

Lead Sponsor Collaborator
German Cancer Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myocardial infraction Incident cases of primary myocardial infarction according to clinical records 1994 - 2009
Primary Stroke Incident cases of primary stroke according to clinical records 1994 - 2009
Primary Cardiovascular death Incident cases of cardiovascular death according to death certificates 1994 - 2009
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