- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00456729
Malabsorption as a Cause of Iron Treatment Failure in Infants
April 4, 2007 updated by: HaEmek Medical Center, Israel
Malabsorption as a Cause of Iron Treatment Failure in Infants - A Clinical Observational Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Afula, Israel, 18101
- Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 4 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Hgb level
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Secondary Outcome Measures
Outcome Measure |
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Iron level
|
Ferritin Level
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tania Hanchis, MD, Pediatric Dpt B - Ha'Emek Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Completion (ACTUAL)
July 1, 2006
Study Registration Dates
First Submitted
April 4, 2007
First Submitted That Met QC Criteria
April 4, 2007
First Posted (ESTIMATE)
April 5, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
April 5, 2007
Last Update Submitted That Met QC Criteria
April 4, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Hematologic Diseases
- Gastrointestinal Diseases
- Intestinal Diseases
- Anemia, Hypochromic
- Anemia
- Iron Metabolism Disorders
- Anemia, Iron-Deficiency
- Malabsorption Syndromes
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Metronidazole
Other Study ID Numbers
- 4150905.EMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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