Helicobacter Pylori and Iron Deficiency: Prevalence of Association and Effect of Therapy

NCT00475527 | Withdrawn Phase 4

• 1 other identifier: HP-HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Iron-Deficiency; Helicobacter Pylori

Outcome Measures

Primary Outcomes (1)

• 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.

  two years

Secondary Outcomes (1)

• 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.

  2 years

Study Arms (2)

iron only

NO INTERVENTION

Only iron therapy

iron + HP therapy

EXPERIMENTAL

Iron + 'omeprazole,clarithromycin,amoxicillin (or metronidazole)

Drug: omeprazole,clarithromycin,amoxicillin (or metronidazole)

Interventions

omeprazole,clarithromycin,amoxicillin (or metronidazole) DRUG

iron + HP therapy

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Children with clinical symptoms fo Helicobacter Pylori, i.e. abdominal pain, peptic ulcer etc.
• Children with underlying chronic disease needing medical treatment.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Omeprazole; Metronidazole

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Study Officials

• Shoshana Revel-Vilk, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 15, 2007
• First Posted: May 21, 2007
• Last Updated: August 20, 2015

Record last verified: 2009-01

Locations

IL (1)