Malabsorption as a Cause of Iron Treatment Failure in Inf... | NCT00456729

Studies
Malabsorption as a Cause of Iron Treatment Failure in Infants

NCT00456729

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Apr 5, 2007Estimated

Enrollment

100

Phase

Not Applicable

Conditions

Iron Deficiency
Malabsorption

Interventions

Metronidazole
Blood tests

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Jul 2006Actual

First Submitted Date

Apr 4, 2007

First Submission Date that Met QC Criteria

Apr 4, 2007

First Posted Date

Apr 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2007

Last Update Posted Date

Apr 5, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Measure	Description	Time Frame
Hgb level

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

4 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ariel Koren, MD	Pediatric Hematology Unit, Ha'Emek Medical Center	Study Director
Carina Levin, MD	Pediatric Hematology Unit - Ha'Emek Medical Center	Principal Investigator
Tania Hanchis, MD	Pediatric Dpt B - Ha'Emek Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center		Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000090463	Iron Deficiencies
D008286	Malabsorption Syndromes
D005873	Giardiasis

Ancestor Terms

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008795	Metronidazole
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D009593	Nitroimidazoles
D009574	Nitro Compounds
D009930	Organic Chemicals
D007093	Imidazoles

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Metronidazole	Drug
Blood tests	Procedure