Back to resultsMalabsorption as a Cause of Iron Treatment Failure in Infants
Primary Purpose
Iron Deficiency, Malabsorption
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Metronidazole
Blood tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Iron Deficiency focused on measuring Iron deficiency, Malabsorption, Giardiasis
Eligibility 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.
Sites / Locations
- Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Outcomes
Primary Outcome Measures
Hgb level
Secondary Outcome Measures
Iron level
Ferritin Level
Full Information
NCT ID
NCT00456729
First Posted
April 4, 2007
Last Updated
April 4, 2007
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00456729
Brief Title
Malabsorption as a Cause of Iron Treatment Failure in Infants
Official Title
Malabsorption as a Cause of Iron Treatment Failure in Infants - A Clinical Observational Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Malabsorption
Keywords
Iron deficiency, Malabsorption, Giardiasis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Type
Procedure
Intervention Name(s)
Blood tests
Primary Outcome Measure Information:
Title
Hgb level
Secondary Outcome Measure Information:
Title
Iron level
Title
Ferritin Level
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel Koren, MD
Organizational Affiliation
Pediatric Hematology Unit, Ha'Emek Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carina Levin, MD
Organizational Affiliation
Pediatric Hematology Unit - Ha'Emek Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tania Hanchis, MD
Organizational Affiliation
Pediatric Dpt B - Ha'Emek Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Malabsorption as a Cause of Iron Treatment Failure in Infants
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