- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00414479
Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment
January 13, 2010 updated by: DBL -Institute for Health Research and Development
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kisumu, Kenya
- Kenya Medical Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
children 9-12 years of age
Description
Inclusion Criteria:
- school children between 9 to 12 year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
children 9-12 years of age
Children with schistosomiasis, malaria and anaemia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
hemoglobin level
|
Secondary Outcome Measures
Outcome Measure |
---|
Schistosomiasis infection
|
malaria infection
|
iron deficiency
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Diana Karanja, DR, Kenya Medical Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
December 20, 2006
First Submitted That Met QC Criteria
December 20, 2006
First Posted (Estimate)
December 21, 2006
Study Record Updates
Last Update Posted (Estimate)
January 14, 2010
Last Update Submitted That Met QC Criteria
January 13, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRP-KY-DK-06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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