We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Is Helicobacter Pylori Infection a Cause or Treatment Failure of Iron Deficiency Anemia in Children in Bangladesh?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00284700
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : February 1, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
Helicobacter pylori is recognized as a major gastrointestinal pathogen in developing countries. This microorganism infects up to 60% of children less than five years in those countries and is strongly associated with chronic gastritis and peptic ulcer disease in children and adults. The progression of gastritis to atrophy often leads to decreased gastric acid output, which is a well-known risk factor for anemia. Gastric acid is essential for increasing the bioavailability and absorption of non-heme dietary iron, the most important source of iron in developing countries. Numerous reports suggest that iron malabsorption secondary to low gastric acid output is a problem in developing world countries. It has been further observed that iron deficiency anemia is resistant to iron therapy particularly in these countries. In a recently completed study we observed an association of anaemia with H. pylori infection. We hypothesize that the poor bioavailability of iron in these countries could be related to H. pylori -induced low gastric acid output and we propose to investigate the role of H. pylori infection as a cause of anemia and treatment failure of iron supplementation in Bangladesh. A prospective, randomized, double-blind, placebo-controlled field trial is proposed among four groups ( 65 each) of H. Pylori infected children of 2-5 years of age with iron deficiency anemia. The children will be assigned to one of the four therapies: antibiotics alone (for H. Pylori eradication), antibiotic plus iron therapy, iron therapy alone, or placebo. Hemoglobin concentration, serum ferritin concentration, and transferrin receptor will be measured before and at 1 and 3 month after the intervention. We also propose a complementary study in an additional 20 children with H. Pylori infection and iron deficiency anemia to assess iron absorption with application of double stable isotopes. The change in hematological parameters will also be compared among the groups before and after the therapy. The results of this study are expected to have implications in the prevention and treatment of iron deficiency anemia in developing countries.

Condition or disease Intervention/treatment
Helicobacter Pylori Infection Iron Deficiency Anemia Not Severely Malnourished No Systemic Infection Children Drug: Iron

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Is Helicobacter Pylori Infection a Cause or Treatment Failure of Iron Deficiency Anemia in Children in Bangladesh?
Study Start Date : December 1997
Estimated Study Completion Date : May 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Iron status

Secondary Outcome Measures :
  1. Prevalence of iron deficiency anemia

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Iron deficiency anemic children
  • with weight for age >60% of National Center for Health Statistics
  • no evidence of deficiency diseases or systemic infection
  • Informed consent of the parents

Exclusion Criteria:

  • Acute infection or apparent inflammatory process
  • Signs of vitamins deficiency
  • Severe anemia (Hemoglobin <70 G/l)
  • Severe malnutrition (marasmus, marasmic kwasiorkar or kwasiorkar)
  • Presence of hook worms and /or Giardia lamblia (cyst or vegetative form) in a stool microscopic examination
  • Presence of fat in a stool microscopic examination
  • Presence of occult blood in a stool as demonstrated by Guaiac test
  • History of taking antibiotics or any drugs for any cause in the preceding month
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284700


Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Shafiqul A Sarker, MBBS,MD International Centre for Diarrhoeal Disease Research, Bangladesh
More Information

ClinicalTrials.gov Identifier: NCT00284700     History of Changes
Other Study ID Numbers: ICDDRB 97-004
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: February 1, 2006
Last Verified: January 2006

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Helicobacter pylori
Iron deficiency anemia
children

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Anemia, Hypochromic
Infection
Communicable Diseases
Deficiency Diseases
Helicobacter Infections
Malnutrition
Sepsis
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Gram-Negative Bacterial Infections
Bacterial Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs