Is Helicobacter Pylori Infection a Cause or Treatment Failure of Iron Deficiency Anemia in Children in Bangladesh?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 260
- Locations
- 2
- Primary Endpoint
- Iron status
Study Overview
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.
Detailed Description
We propose to complementary study:
- A prospective, double-blind, placebo-controlled field trial in two hundred sixty children of a peri-urban community near Dhaka City is proposed.
- The assessment of iron absorption before and after anti-infective therapy in 20 children with H. Pylori infection and iron deficiency anemia
- Field trial
1.1 Description of the study population Children will be recruited from Nandipara, a peri-urban community situated 7 miles northeast of Dhaka City. This community has a population of 3,500 in an area of approximately 2.5 square miles. Among the residents, 70% of males are classified as day laborers, 20% are rickshaw pullers, and 5% are carpenters or service holders. Fifteen percent of women are day laborers and 85% are housewives. The average family size is 4.5 members. The slum has a municipal water supply for drinking and cooking and most families live in poorly constructed houses. The great majority of houses are mud walled with thatched dry leaves and bamboo or tin roofs. The population less than five years of age is about 700. The prevelance of H. pylori infection in less than five children in this community is 50%.44 A weekly clinic has been run by the International Centre for Diarrhoeal Diseases Research, Bangladesh (ICDDR,B) for minor case of illness in the population since 1986.
All children in the community will initially be screened for iron deficiency anemia and H. pylori infection. After explanation of the study and the tests, informed consent will be obtained from the parents or legal guardians. Demographic information including name, date of birth, sex, weight, height, economic status of the parents, nature of feeding, and previous medication in the past 1 month will be recorded.
Screening for iron deficiency anemia 50 µl capillary blood samples obtained by fingerstick will be assessed for hemoglobin (Hgb) concentration. Measurement of hemoglobin concentration is the most useful test in screening iron deficiency anemia since it directly reflects the quantity of most abundant essential iron compound in the body. Children with hemoglobin concentration below 110g/l will be considered as anemic. In children with low Hgb identified through the initial screening, the diagnosis of iron deficiency anemia will be confirmed by venepuncture Hgb, serum ferritin concentration, and serum transferrin receptor concentration. Haemoglobin concentration can be transiently depressed due to inflammation or infection, and in such a situation does not indicate pathological anemia. Of all the biochemical tests for assessing iron status, a low SF is the most specific test for iron deficiency. The major disadvantage of SF is that it is readily elevated in response to any infector inflammatory condition. One major advantage of sTfR is that unlike SF, sTfR is not significantly effected by infection or the inflammatory process. However, sTfR levels are increased in situations of increased RBC turnover such as hemolytic anemia, i.e. thalassemia, etc. A uniform cutoff value of >8.5 mg/l indicates an elevated sTfR and therefore iron deficiency or hemolytic anaemia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 2 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Iron status
Secondary Outcomes
- Prevalence of iron deficiency anemia