Malabsorption as a Cause of Iron Treatment Failure in Infants

This study has been completed.

First Received: April 4, 2007 No Changes Posted

Sponsor:	HaEmek Medical Center, Israel
Information provided by:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00456729

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:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Malabsorption as a Cause of Iron Treatment Failure in Infants - A Clinical Observational Study

Resource links provided by NLM:

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Metronidazole

U.S. FDA Resources

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

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

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

Keywords provided by HaEmek Medical Center, Israel:

Iron deficiency
Malabsorption
Giardiasis

Additional relevant MeSH terms:

Anti-Infective Agents
Metronidazole
Antiprotozoal Agents
Metabolic Diseases
Gastrointestinal Diseases
Hematologic Diseases
Physiological Effects of Drugs
Anemia, Hypochromic
Anemia

Iron Metabolism Disorders
Intestinal Diseases
Pharmacologic Actions
Anemia, Iron-Deficiency
Antiparasitic Agents
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Malabsorption Syndromes

ClinicalTrials.gov processed this record on February 09, 2010