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

This study has been completed.
Sponsor:
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00284700
First received: January 31, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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 Intervention
Helicobacter Pylori Infection
Iron Deficiency Anemia
Not Severely Malnourished
No Systemic Infection
Children
Drug: Iron

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Is Helicobacter Pylori Infection a Cause or Treatment Failure of Iron Deficiency Anemia in Children in Bangladesh?

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Iron status

Secondary Outcome Measures:
  • Prevalence of iron deficiency anemia

Estimated Enrollment: 260
Study Start Date: December 1997
Estimated Study Completion Date: May 2001
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00284700     History of Changes
Other Study ID Numbers: ICDDRB 97-004
Study First Received: January 31, 2006
Last Updated: January 31, 2006
Health Authority: Bangladesh: Ethical Review Committee

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

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

ClinicalTrials.gov processed this record on August 28, 2014