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NCT00456729 Clinical Trial

Malabsorption as a Cause of Iron Treatment Failure in Infants

Iron Deficiency Clinical Trial

Official title:
Malabsorption as a Cause of Iron Treatment Failure in Infants - A Clinical Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00456729
Other study ID # 4150905.EMC
Secondary ID
Status Completed
Phase N/A
First received April 4, 2007
Last updated April 4, 2007
Start date May 2006
Est. completion date July 2006

Study information
Verified date January 2007
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 4 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Metronidazole

Procedure:
• Blood tests

Locations
Country Name City State
Israel Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center Afula

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hgb level
Secondary Iron level
Secondary Ferritin Level
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