Malabsorption as a Cause of Iron Treatment Failure in Infants

This study has been completed.
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00456729
First received: April 4, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   6 Months to 4 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00456729     History of Changes
Other Study ID Numbers: 4150905.EMC
Study First Received: April 4, 2007
Last Updated: April 4, 2007
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 31, 2014