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Gastrointestinal Evaluation in Young Men With Iron Deficiency Anemia

NCT ID: NCT00498511

Last Updated: 2007-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Brief Summary

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Both upper gastrointestinal endoscopy and colonoscopy are recommended in men and post-menopausal women with iron deficiency anemia. Due to lack of data on the yield of these endoscopies in young men, they are currently investigated as older men. The aim of this study is to evaluate prospectively the prevalence of various gastrointestinal lesions in young men with iron deficiency anemia. Our hypothesis is that the diagnostic yield of colonoscopy in young anemic men without gastrointestinal symptoms is very low, especially if a potential lesion is detected during upper gastrointestinal endoscopy. Therefore, this study will try to identify predicting factors regarding the yield of both endoscopies. Another purpose is to evaluate the outcome of patients with negative endoscopic results, during a follow-up of two years.

Detailed Description

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Conditions

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Anemia, Iron-Deficiency

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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upper gastrointestinal endoscopy, colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Men \< 40 years old of age with iron deficiency.
* hemoglobin level less than 13 gr/dl documented during the 2 years prior to entering the study with one of the following: 1) iron level less than 45 μg /dl and transferrin saturation less than 10%; 2) ferritin level less than 20 μg/L (both documented during the 4 months prior to entering the study).

Exclusion Criteria

* Previously diagnosed disease that explain iron deficiency anemia
* Colonoscopy performed during the last 4 years
* Upper gastrointestinal endoscopy performed during the last 2 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Alain Nimrod Kimchi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Gastroenterology and Liver Diseases, Assaf-Harofeh Medical Center, 70300 Zerifin, Israel

Locations

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Institute of Gastroenterology and Liver Diseases, Assaf harofeh Medical Center

Ẕerifin, , Israel

Site Status

Countries

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Israel

Central Contacts

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Alain Nimrod Kimchi, M.D.

Role: CONTACT

[email protected]
972-08-9779722

Efrat Broide, M.D.

Role: CONTACT

[email protected]
972-08-9779793

Other Identifiers

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64/07

Identifier Type: -

Identifier Source: org_study_id