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Gastrointestinal Evaluation in Young Men With Iron Deficiency Anemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00498511
First received: July 8, 2007
Last updated: July 12, 2007
Last verified: June 2007
  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
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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00498511     History of Changes
Other Study ID Numbers: 64/07
Study First Received: July 8, 2007
Last Updated: July 12, 2007
Health Authority: Israel: Ministry of Health

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
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2014