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Helicobacter Pylori Eradication Trial to Reduce Iron Deficiency in Children

NCT00364104 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2009-06-30

No results posted yet for this study

Summary

The investigators hypothesize that the Helicobacter pylori bacterium decreases iron from the stomach and that this effect of the infection can be identified among persons with iron deficiency as well as among persons with normal iron stores. The aim of this study is to determine whether Helicobacter pylori eradication in children is followed by an increase in markers of iron stores after six to twelve months of treatment.

Conditions

Interventions

DRUG

Quadruple sequential Helicobacter pylori eradication + iron sulfate

A 10-day course of Hp infection sequential eradication therapy plus 6-weeks of iron supplementation

DRUG

Quadruple sequential Helicobacter pylori eradication therapy

A 10-day course of Hp infection sequential eradication therapy only plus 6-weeks of matching placebo of iron supplementation

DRUG

Ferrous sulfate

6-weeks of iron supplementation only plus 10-days matching placebo of Hp infection eradication therapy

DRUG

Placebo

Placebo only (10-days of matching placebo of Hp eradication therapy and 6-weeks of matching iron supplementation).

Sponsors & Collaborators

  • Texas Tech University

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • University of North Texas Health Science Center

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Victor M Cardenas, MD, MPH, PhD · University of Texas-Houston School of Public Health El Paso Regional Campus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
36 Months
Max Age
120 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00364104 on ClinicalTrials.gov