Helicobacter Pylori and Iron Deficiency: Prevalence of Association and Effect of Therapy
Primary Purpose
Anemia, Iron-Deficiency, Helicobacter Pylori
Status
Withdrawn
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
omeprazole,clarithromycin,amoxicillin (or metronidazole)
Sponsored by
About this trial
This is an interventional treatment trial for Anemia, Iron-Deficiency
Eligibility Criteria
Inclusion Criteria:
- All of the children diagnosed with IDA at six large ambulatory pediatrics clinics from the Jerusalem district.
- The diagnosis of IDA would be defined as a low hemoglobin level in the presence of iron deficiency (low iron levels, high transferrin saturation and/or low ferritin).
Exclusion Criteria:
- Children with clinical symptoms fo Helicobacter Pylori, i.e. abdominal pain, peptic ulcer etc.
- Children with underlying chronic disease needing medical treatment.
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
iron only
iron + HP therapy
Arm Description
Only iron therapy
Iron + 'omeprazole,clarithromycin,amoxicillin (or metronidazole)
Outcomes
Primary Outcome Measures
To compare the raise in hemoglobin level between baseline and eight weeks later in Fe-supplemented and HP-positive children treated for HP infection and Fe-supplemented HP-positive children not treated for HP.
Secondary Outcome Measures
1. To determine the prevalence of HP infection in children with IDA in Israel, 2. To compare the demographic, clinical and laboratory findings between children diagnosed with IDA with/without HP infection.
Full Information
NCT ID
NCT00475527
First Posted
May 15, 2007
Last Updated
August 19, 2015
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00475527
Brief Title
Helicobacter Pylori and Iron Deficiency: Prevalence of Association and Effect of Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Withdrawn
Why Stopped
problem of accrual
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Iron deficiency anemia (IDA) is a major health problem in children, effecting up to 20% of young children. Helicobacter pylori (HP) infection is also reported to be prevalent in children. Several large epidemiologic studies support an association between HP infection and lower iron stores. Other small studies suggest improvement in anemia following HP treatment.
We assume that the prevalence of HP infection in Israeli children diagnosed with IDA is high and that that adding therapy for HP in those children will improve the response to iron deficiency.
Detailed Description
This is a prospective randomized control study which will be conducted at six large ambulatory pediatrics clinics from the Jerusalem district. All of the children diagnosed with IDA would be eligible to join the study after informed consent will be obtained. Ethics committee approval is obtained. Analysis of stool samples will be carried out by the HP Stool antigen EIA (HpSA, Premier Platinum HpSA, Meridian Diagnostics inc, Cincinnati, OH, USA). All children enrolled will be treated with standard Fe therapy. Children with positive HpSA will be randomized, controlled for age and clinic, to receive or not receive antibiotics treatment. Assessment of response to iron therapy will be done at eight weeks later. The prevalence of HP infection in children with diagnosed with IDA would be reported. Statistical analysis will compare the baseline data between HP-positive and -negative children and the response to Fe between the three study groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron-Deficiency, Helicobacter Pylori
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iron only
Arm Type
No Intervention
Arm Description
Only iron therapy
Arm Title
iron + HP therapy
Arm Type
Experimental
Arm Description
Iron + 'omeprazole,clarithromycin,amoxicillin (or metronidazole)
Intervention Type
Drug
Intervention Name(s)
omeprazole,clarithromycin,amoxicillin (or metronidazole)
Primary Outcome Measure Information:
Title
To compare the raise in hemoglobin level between baseline and eight weeks later in Fe-supplemented and HP-positive children treated for HP infection and Fe-supplemented HP-positive children not treated for HP.
Time Frame
two years
Secondary Outcome Measure Information:
Title
1. To determine the prevalence of HP infection in children with IDA in Israel, 2. To compare the demographic, clinical and laboratory findings between children diagnosed with IDA with/without HP infection.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All of the children diagnosed with IDA at six large ambulatory pediatrics clinics from the Jerusalem district.
The diagnosis of IDA would be defined as a low hemoglobin level in the presence of iron deficiency (low iron levels, high transferrin saturation and/or low ferritin).
Exclusion Criteria:
Children with clinical symptoms fo Helicobacter Pylori, i.e. abdominal pain, peptic ulcer etc.
Children with underlying chronic disease needing medical treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shoshana Revel-Vilk, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
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Helicobacter Pylori and Iron Deficiency: Prevalence of Association and Effect of Therapy
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