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Malabsorption as a Cause of Iron Treatment Failure in Infants

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ClinicalTrials.gov Identifier: NCT00456729
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : April 5, 2007
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Iron Deficiency Malabsorption Drug: Metronidazole Procedure: Blood tests

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : May 2006
Study Completion Date : July 2006

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U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Hgb level

Secondary Outcome Measures :
  1. Iron level
  2. Ferritin Level

Eligibility Criteria

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

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

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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

Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
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 Posted: April 5, 2007    Key Record Dates
Last Update Posted: April 5, 2007
Last Verified: January 2007

Keywords provided by HaEmek Medical Center, Israel:
Iron deficiency

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