Gastrointestinal Evaluation in Young Men With Iron Deficiency Anemia

Anemia, Iron-Deficiency Clinical Trial

Official title:

Prospective Evaluation of the Gastrointestinal Tract in Young Men With Iron Deficiency Anemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00498511
• Other study ID #: 64/07
• Status: Not yet recruiting
• Phase: N/A
• First received: July 8, 2007
• Last updated: July 12, 2007
• Start date: August 2007

Study information

• Verified date: June 2007
• Source: Assaf-Harofeh Medical Center
• Contact: Alain Nimrod Kimchi, M.D.
• Phone: 972-08-9779722
• Email: nimrodk[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Intervention

Procedure:
• upper gastrointestinal endoscopy, colonoscopy

Locations

Country	Name	City	State
Israel	Institute of Gastroenterology and Liver Diseases, Assaf harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel,