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Malabsorption as a Cause of Iron Treatment Failure in Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00456729
First Posted: April 5, 2007
Last Update Posted: July 25, 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:
HaEmek Medical Center, Israel
  Purpose
Infants should receive prophylacatic iron supplementation since age 4 months till one year. Patients suffering from malabsorption, mainly Giardia infestation may develop iron deficiency resistent to further iron treatment. The purpose of this study is to assess the incidence of malabsorption in those infants and to examine the results of empiric treatment with metronidazole.

Condition Intervention
Iron Deficiency Malabsorption Drug: Metronidazole Procedure: Blood tests

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Malabsorption as a Cause of Iron Treatment Failure in Infants - A Clinical Observational Study

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Hgb level

Secondary Outcome Measures:
  • Iron level
  • Ferritin Level

Estimated Enrollment: 100
Study Start Date: May 2006
Study Completion Date: July 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All infants referred to the Pediatric Hematology Unit because lack of response to iron treatment.

Exclusion Criteria:

  • Patients diagnosed with specific malabsorption causes like Celiac or Cystic Fibrosis.
  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): NCT00456729


Locations
Israel
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Study Director: Ariel Koren, MD Pediatric Hematology Unit, Ha'Emek Medical Center
Principal Investigator: Carina Levin, MD Pediatric Hematology Unit - Ha'Emek Medical Center
Principal Investigator: Tania Hanchis, MD Pediatric Dpt B - Ha'Emek Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00456729     History of Changes
Other Study ID Numbers: 4150905.EMC
First Submitted: April 4, 2007
First Posted: April 5, 2007
Last Update Posted: July 25, 2007
Last Verified: January 2007

Keywords provided by HaEmek Medical Center, Israel:
Iron deficiency
Malabsorption
Giardiasis

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Malabsorption Syndromes
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents