Clinical Trial: Helicobacter Pylori Eradication Trial to Reduce Iron Deficiency in Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized Field Intervention Trial of H. Pylori Eradication to Reduce Iron Deficiency Among Children in El Paso, Texas
Brief 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.
Detailed Summary:
For the last 12 years, scientific evidence has mounted linking Helicobacter pylori infection with iron deficiency and iron deficiency anemia. Reports from around the world on several cases of iron deficiency anemia refractory to iron supplementation among children infected with Helicobacter pylori, most without evident ulcers, clearly indicate that such cases have been cured of their anemia after receiving a course of Helicobacter pylori eradication therapy. Several studies based on national surveys, including one on the U.S. National Health and Nutrition Examination Survey data and conducted by the authors of this proposal, have found an association between Helicobacter pylori infection and the levels of iron stores. However, these studies fail to demonstrate that anemia follows Helicobacter pylori infection. Moreover, most previous research has been conducted outside of the contiguous U.S. and has not included young children, one of the high-risk populations for iron deficiency and iron deficiency anemia. Data on this age-group is most needed to develop sound public health interventions.
We propose to conduct such a study among children living in El Paso, Texas, a city located on the U.S.-Mexico border. A series of studies have been conducted in that city by the authors of this proposal, including a National Institutes of Health sponsored study aiming to describe the natural history of Helicobacter pylori infection in children from birth to age seven years (84 months). We 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. Currently, the clinical management of the most extreme form of iron deficiency, that is iron deficiency anemia, relies only on supplemental iron therapy. For ethical reasons, our st
Sponsor: The University of Texas Health Science Center, Houston
Current Primary Outcome:
- Percent change of serum ferritin [ Time Frame: between 6 and 12 months ]
- Percent change of transferrin saturation [ Time Frame: between 6 and 12 months ]
- Percent change of hemoglobin [ Time Frame: between 6 and 12 months ]
Original Primary Outcome:
- Percent change of serum ferritin
- Percent change of transferrin saturation
- Percent change of hemoglobin
Current Secondary Outcome: Proportion of children who cleared their H. pylori infection [ Time Frame: 45+ days after completing treatment ]
Original Secondary Outcome: Proportion of children who cleared their H. pylori infection
Information By: The University of Texas Health Science Center, Houston
Dates:
Date Received: August 14, 2006
Date Started: March 2007
Date Completion:
Last Updated: June 26, 2009
Last Verified: June 2009
