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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
July 8, 2007
July 10, 2007
July 13, 2007
August 2007
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Complete list of historical versions of study NCT00498511 on ClinicalTrials.gov Archive Site
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Gastrointestinal Evaluation in Young Men With Iron Deficiency Anemia
Prospective Evaluation of the Gastrointestinal Tract in Young Men With Iron Deficiency Anemia
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.
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Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
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Anemia, Iron-Deficiency
Procedure: upper gastrointestinal endoscopy, colonoscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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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
Sexes Eligible for Study: Male
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00498511
64/07
No
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Assaf-Harofeh Medical Center
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Principal Investigator: Alain Nimrod Kimchi, M.D. Institute of Gastroenterology and Liver Diseases, Assaf-Harofeh Medical Center, 70300 Zerifin, Israel
Assaf-Harofeh Medical Center
June 2007