Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-02 @ 3:42 PM
Study NCT ID:
NCT00364104
Status:
COMPLETED
Last Update Posted:
2009-06-30
First Post:
2006-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helicobacter Pylori Eradication Trial to Reduce Iron Deficiency in Children
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
Randomized Field Intervention Trial of H. Pylori Eradication to Reduce Iron Deficiency Among Children in El Paso, Texas
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEIDC
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 Description:
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 study will identify children with anemia from the study, and will assign them to one of the arms receiving iron supplementation. Our study will determine whether a combination of iron supplementation and sequential Helicobacter pylori eradication therapy yields higher increases of iron stores than each of these treatments alone. To summarize, our main hypothesis is that Helicobacter pylori infection is associated with iron deficiency such that Helicobacter pylori eradication would result in an increase in the levels of:
1. serum ferritin,
2. transferrin saturation, and
3. hemoglobin.
To test these hypotheses we will randomly assign 125 Helicobacter pylori-infected children (3 to 10 years of age) into each of the following four groups: Helicobacter pylori eradication treatment, iron supplementation, Helicobacter pylori eradication plus iron supplementation, or placebo. We plan to recruit infected children through a household survey in El Paso, screen their Helicobacter pylori infection status by a stool test, and invite their parents to undergo a confirmatory breath test. Infected children randomly allocated to those four arms of the study will be followed closely during the 6 weeks they are taking the study medication to record any adverse event, followed by a visit at 45 days after treatment to tell whether or not those receiving the medication had their infection eradicated, between 6 and 12 months for hematological evaluation to compare with the baseline levels of iron stores.
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 study will identify children with anemia from the study, and will assign them to one of the arms receiving iron supplementation. Our study will determine whether a combination of iron supplementation and sequential Helicobacter pylori eradication therapy yields higher increases of iron stores than each of these treatments alone. To summarize, our main hypothesis is that Helicobacter pylori infection is associated with iron deficiency such that Helicobacter pylori eradication would result in an increase in the levels of:
1. serum ferritin,
2. transferrin saturation, and
3. hemoglobin.
To test these hypotheses we will randomly assign 125 Helicobacter pylori-infected children (3 to 10 years of age) into each of the following four groups: Helicobacter pylori eradication treatment, iron supplementation, Helicobacter pylori eradication plus iron supplementation, or placebo. We plan to recruit infected children through a household survey in El Paso, screen their Helicobacter pylori infection status by a stool test, and invite their parents to undergo a confirmatory breath test. Infected children randomly allocated to those four arms of the study will be followed closely during the 6 weeks they are taking the study medication to record any adverse event, followed by a visit at 45 days after treatment to tell whether or not those receiving the medication had their infection eradicated, between 6 and 12 months for hematological evaluation to compare with the baseline levels of iron stores.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: