Gastrointestinal Evaluation in Young Men With Iron Deficiency Anemia

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00498511
Collaborator
(none)
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: upper gastrointestinal endoscopy, colonoscopy

Study Design

Study Type:
Observational
Observational Model:
Defined Population
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of the Gastrointestinal Tract in Young Men With Iron Deficiency Anemia
Study Start Date :
Aug 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Gastroenterology and Liver Diseases, Assaf harofeh Medical Center Zerifin Israel 70300

    Sponsors and Collaborators

    • Assaf-Harofeh Medical Center

    Investigators

    • Principal Investigator: Alain Nimrod Kimchi, M.D., Institute of Gastroenterology and Liver Diseases, Assaf-Harofeh Medical Center, 70300 Zerifin, Israel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00498511
    Other Study ID Numbers:
    • 64/07
    First Posted:
    Jul 10, 2007
    Last Update Posted:
    Jul 13, 2007
    Last Verified:
    Jun 1, 2007

    Study Results

    No Results Posted as of Jul 13, 2007