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Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414479
First Posted: December 21, 2006
Last Update Posted: January 14, 2010
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.
Information provided by:
DBL -Institute for Health Research and Development
  Purpose
The purpose of this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency).

Condition Intervention
Anaemia Schistosomiasis Infection Malaria Iron Deficiency Drug: praziquantl, iron, ACT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment

Resource links provided by NLM:


Further study details as provided by DBL -Institute for Health Research and Development:

Primary Outcome Measures:
  • hemoglobin level

Secondary Outcome Measures:
  • Schistosomiasis infection
  • malaria infection
  • iron deficiency

Enrollment: 1500
Study Start Date: July 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
children 9-12 years of age
Children with schistosomiasis, malaria and anaemia
Drug: praziquantl, iron, ACT

Detailed Description:
The study will be carried out in an area around Lake Victoria in Kenya where the prevalence of schistosomiasis and malaria are highest in the areas nearest to the Lake. Depending on the prevalence of schistosomiasis a sample of between 876 to 2.524 children will be enrolled in the study. The children who will be in the age between 9 to 12 year, will have their stool and urine examined for schistosomiasis and intestinal worms and a blood sample will be examined for malaria parasites and the hemoglobin level. Children will also be weight, measured and examined by a doctor and register their food intake over one week, to determine their nutritional status. Children who are found to be infected with schistosomiasis, intestinal worms or malaria will be offered treatment. Children who are found to have anemia will be offered a course of iron supplementation, children with severe anemia will be referred to the nearest health facility for treatment. 12 months after the initial examinations and treatment all children will have a re-examination of their stool, urine and blood.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children 9-12 years of age
Criteria

Inclusion Criteria:

  • school children between 9 to 12 year
  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): NCT00414479


Locations
Kenya
Kenya Medical Research Institute
Kisumu, Kenya
Sponsors and Collaborators
DBL -Institute for Health Research and Development
Investigators
Principal Investigator: Diana Karanja, DR Kenya Medical Research Institute
  More Information

ClinicalTrials.gov Identifier: NCT00414479     History of Changes
Other Study ID Numbers: SRP-KY-DK-06
First Submitted: December 20, 2006
First Posted: December 21, 2006
Last Update Posted: January 14, 2010
Last Verified: January 2010

Keywords provided by DBL -Institute for Health Research and Development:
schistosomiasis
anaemia
malaria
iron deficiency

Additional relevant MeSH terms:
Schistosomiasis
Anemia
Malaria
Anemia, Iron-Deficiency
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Trematode Infections
Helminthiasis