NCT00498511

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.

Trial Health

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Trial Health Score

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Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
Last Updated

July 13, 2007

Status Verified

June 1, 2007

First QC Date

July 8, 2007

Last Update Submit

July 12, 2007

Conditions

Keywords

Anemia, Iron-DeficiencyEndoscopy, GastrointestinalMale, aged 18 to 40

Interventions

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Previously diagnosed disease that explain iron deficiency anemia
  • Colonoscopy performed during the last 4 years
  • Upper gastrointestinal endoscopy performed during the last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Gastroenterology and Liver Diseases, Assaf harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Endoscopy, Digestive SystemColonoscopy

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresEndoscopy, Gastrointestinal

Study Officials

  • Alain Nimrod Kimchi, M.D.

    Institute of Gastroenterology and Liver Diseases, Assaf-Harofeh Medical Center, 70300 Zerifin, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain Nimrod Kimchi, M.D.

CONTACT

Efrat Broide, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 8, 2007

First Posted

July 10, 2007

Study Start

August 1, 2007

Last Updated

July 13, 2007

Record last verified: 2007-06

Locations