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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414479
• Other study ID #: SRP-KY-DK-06
• Status: Completed
• Phase: N/A
• First received: December 20, 2006
• Last updated: January 13, 2010
• Start date: July 2006
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: DBL -Institute for Health Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

• school children between 9 to 12 year

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anaemia
• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency
• Malaria
• Schistosomiasis
• Schistosomiasis Infection

Intervention

Drug:
• praziquantl, iron, ACT

Locations

Country	Name	City	State
Kenya	Kenya Medical Research Institute	Kisumu

Sponsors (1)

Lead Sponsor	Collaborator
DBL -Institute for Health Research and Development

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin level
Secondary	Schistosomiasis infection
Secondary	malaria infection
Secondary	iron deficiency