Helicobacter Pylori Eradication Trial to Reduce Iron Deficiency in Children (HEIDC)

This study has been completed.
Sponsor:
Collaborators:
Texas Tech University
University of Texas
Baylor College of Medicine
University of North Texas Health Science Center
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00364104
First received: August 14, 2006
Last updated: June 26, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Iron Deficiency
Drug: Quadruple sequential Helicobacter pylori eradication + iron sulfate
Drug: Quadruple sequential Helicobacter pylori eradication therapy
Drug: Ferrous sulfate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Field Intervention Trial of H. Pylori Eradication to Reduce Iron Deficiency Among Children in El Paso, Texas

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Percent change of serum ferritin [ Time Frame: between 6 and 12 months ] [ Designated as safety issue: No ]
  • Percent change of transferrin saturation [ Time Frame: between 6 and 12 months ] [ Designated as safety issue: No ]
  • Percent change of hemoglobin [ Time Frame: between 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of children who cleared their H. pylori infection [ Time Frame: 45+ days after completing treatment ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
A 10-day course of Hp infection sequential eradication therapy plus 6-weeks of iron supplementation
Drug: Quadruple sequential Helicobacter pylori eradication + iron sulfate
A 10-day course of Hp infection sequential eradication therapy plus 6-weeks of iron supplementation
Experimental: B
The 10-day course of Hp infection sequential eradication therapy only plus 6-weeks of matching placebo 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
Experimental: C
6-weeks of iron supplementation only plus 10-days of matching placebo of Hp infection eradication therapy
Drug: Ferrous sulfate
6-weeks of iron supplementation only plus 10-days matching placebo of Hp infection eradication therapy
Placebo Comparator: D Drug: Placebo
Placebo only (10-days of matching placebo of Hp eradication therapy and 6-weeks of matching iron supplementation).

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.

  Eligibility

Ages Eligible for Study:   36 Months to 120 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children 3-10 years of age
  • Helicobacter pylori infected, asymptomatic
  • Healthy otherwise
  • Parents provided consent/assenting children 7-10 years of age

Exclusion Criteria:

  • Parental consent or child assent not obtained
  • History of antibiotic-related allergic episodes
  • Children with a history of allergy, asthma, hay fever or urticaria
  • Phenylketonurics
  • Abnormal renal and hepatic functions as evaluated through albumin, bilirubin, AST (or SGOT), ALT (or SGPT), alkaline phosphatase and GGT-P
  • History of peptic ulcer
  • History of recent (< 1 month) severe disease
  • History of recent (< 1 month) use of antibiotics, antacids, H2 receptor antagonists, proton pump inhibitors and remedies containing bismuth
  • Parents uncertain about staying in El Paso for the next year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364104

Locations
United States, Texas
Texas Tech University School of Medicine
El Paso, Texas, United States, 79905
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Texas Tech University
University of Texas
Baylor College of Medicine
University of North Texas Health Science Center
Investigators
Principal Investigator: Victor M Cardenas, MD, MPH, PhD University of Texas-Houston School of Public Health El Paso Regional Campus
  More Information

No publications provided by The University of Texas Health Science Center, Houston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Victor M. Cardenas, MD, MPH, PhD, Associate Professor, UT Houston HSC School of Public Health El Paso Regional Campus
ClinicalTrials.gov Identifier: NCT00364104     History of Changes
Other Study ID Numbers: HSC-SPH-06-0374
Study First Received: August 14, 2006
Last Updated: June 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Iron deficiency
Helicobacter infection
Epidemiology

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014