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Gastrointestinal Evaluation in Young Men With Iron Deficiency Anemia

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ClinicalTrials.gov Identifier: NCT00498511
Recruitment Status : Unknown
Verified June 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 10, 2007
Last Update Posted : July 13, 2007
Information provided by:
Assaf-Harofeh Medical Center

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
Anemia, Iron-Deficiency Procedure: upper gastrointestinal endoscopy, colonoscopy

Study Type : Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Gastrointestinal Tract in Young Men With Iron Deficiency Anemia
Study Start Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Endoscopy Iron
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498511

Contact: Alain Nimrod Kimchi, M.D. 972-08-9779722 nimrodk@asaf.health.gov.il
Contact: Efrat Broide, M.D. 972-08-9779793 efibroide@yahoo.com

Institute of Gastroenterology and Liver Diseases, Assaf harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Principal Investigator: Alain Nimrod Kimchi, M.D.         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: Alain Nimrod Kimchi, M.D. Institute of Gastroenterology and Liver Diseases, Assaf-Harofeh Medical Center, 70300 Zerifin, Israel

ClinicalTrials.gov Identifier: NCT00498511     History of Changes
Other Study ID Numbers: 64/07
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: July 13, 2007
Last Verified: June 2007

Keywords provided by Assaf-Harofeh Medical Center:
Anemia, Iron-Deficiency
Endoscopy, Gastrointestinal
Male, aged 18 to 40

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases