Status:
COMPLETED
Antioxidant Micronutrients in Malaria
Lead Sponsor:
University of Lagos, Nigeria
Conditions:
Malaria
Eligibility:
All Genders
6-5 years
Phase:
PHASE3
Brief Summary
In the last decade, the prevalence of malaria has been escalating at an alarming rate, especially in Africa. An estimated 300 to 500 million cases each year cause 1.5 to 2.7 million deaths, more than ...
Detailed Description
The pathogenesis of plasmodial infection hinges on intracellular invasion of host erythrocyte and hepatocyte with possible generation of free radicals that may contribute to cellular membrane damage. ...
Eligibility Criteria
Inclusion
- age of \< 5 years
- asexual parasitemia of between 1,000 and 100,000/µl
- acute manifestation of malaria (e.g., history of fever in the preceding 24 hours or a temperature of \>37.5°C at baseline)
- body weight between 5 and 30 kg
- ability to tolerate oral therapy
- informed consent by the legal representative of the subject (the parents, if possible), oral agreement of the child if appropriate
- resident in the study area for a duration of at least 4 weeks
Exclusion
- adequate antimalarial treatment within the previous 7 days
- use of micronutrients in the last 2 weeks
- antibiotic treatment for a concurrent infection
- hemoglobin level of \<7 g/dl
- hematocrit of \<25%
- leukocyte count of \>15,000/µl
- mixed plasmodial infection
- severe malaria, any other severe underlying disease
- concomitant disease masking assessment of the treatment response
- inflammatory bowel disease, and any other disease causing fever
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01152931
Start Date
August 1 2010
End Date
December 1 2010
Last Update
May 31 2012
Active Locations (2)
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1
Central Primary Health Centre, Ukpenu, Road, Ekpoma.
Ekpoma, Edo, Nigeria, +234
2
Faithdome Medical Centre, Ekpoma.
Ekpoma, Esan West, Edo State, Nigeria, +234