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Gastrointestinal Evaluation in Young Men With Iron Deficiency Anemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00498511
First Posted: July 10, 2007
Last Update Posted: July 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose
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 Intervention
Anemia, Iron-Deficiency Procedure: upper gastrointestinal endoscopy, colonoscopy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Study Start Date: August 2007
  Eligibility

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
Criteria

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
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


Contacts
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

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

ClinicalTrials.gov Identifier: NCT00498511     History of Changes
Other Study ID Numbers: 64/07
First Submitted: July 8, 2007
First Posted: July 10, 2007
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
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases


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