Helicobacter Pylori and Iron Deficiency: Prevalence of Association and Effect of Therapy
Information source: Hadassah Medical Organization
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anemia, Iron-Deficiency; Helicobacter Pylori
Intervention: omeprazole,clarithromycin,amoxicillin (or metronidazole) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hadassah Medical Organization Official(s) and/or principal investigator(s):
Shoshana Revel-Vilk, MD, Principal Investigator, Affiliation: Hadassah Medical Center
Overall contact:
Shoshana Revel-Vilk, MD, Phone: 0097226777408, Email: shoshanav@hadassah.org.il
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.
Clinical Details
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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.
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.
Eligibility
Minimum age: 6 Months.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Shoshana Revel-Vilk, MD, Phone: 0097226777408, Email: shoshanav@hadassah.org.il
Hadassah Medical Organization, Jerusalem, Israel; Recruiting
Arik Tzukert, DMD, Phone: 0097226776095, Email: arik@hadassah.org.il
Hadas Lemberg, PhD, Phone: 0097226777572, Email: lhadas@hadassah.org.il
Shoshana Revel-Vilk, MD, Principal Investigator
Additional Information
Starting date: January 2008
Last updated: January 10, 2008
|
