At a glance
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Randomized Field Intervention Trial of H. Pylori Eradication to Reduce Iron Deficiency Among Children in El Paso, Texas
In Brief
A Phase 3 clinical trial evaluating Quadruple sequential Helicobacter pylori eradication + iron sulfate, Quadruple sequential Helicobacter pylori eradication therapy, and 2 other interventions for Iron Deficiency. Completed, enrolled 125 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
A 10-day course of Hp infection sequential eradication therapy plus 6-weeks of iron supplementation
A 10-day course of Hp infection sequential eradication therapy only plus 6-weeks of matching placebo of iron supplementation
6-weeks of iron supplementation only plus 10-days matching placebo of Hp infection eradication therapy
Placebo only (10-days of matching placebo of Hp eradication therapy and 6-weeks of matching iron supplementation).