Antioxidant Micronutrients in Malaria — AMM  

Malaria Clinical Trial

Official title: Antioxidant Micronutrients in Malaria:a Randomised Clinical Trial

Status Completed

Clinical Trial 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 90% occur in children under 5 years of age in Africa (WHO 1995). Malaria is Africa's leading cause of under-five mortality (20%) and constitutes 10% of the continent's overall disease burden. It accounts for 40% of public health expenditure, 30-50% of inpatient admissions, and up to 50% of outpatient visits in areas with high malaria transmission. Antioxidant micronutrients have immunomodulatory role and may have suppressive activity.

Clinical Trial 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. This will make uninfected erythrocyte and hepatocyte to be more susceptible to merozoite invasion. Zinc and Selenium has immunomodulatory properties. They enhance cell-mediated immune response in malaria infection. This may help to adequately suppress schizont maturation and inhibit the release of merozoites. However, it is possible that they have a direct chemosuppressive or blood schizonticidal effect. The following research questions emanated from this hypothesis;

1. Do the micronutrients in question have direct suppressive or schizonticidal effect?

2. Can they be used as short course therapy with standard antimalarials in uncomplicated malaria?

3. Is their effect enhanced when used in combination with each other or with standard antimalarials?

4. Do they have any prophylactic benefit?

5. Can their use alter the course of established malaria infection? ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT01152931
• Study type: Interventional
• Source: University of Lagos, Nigeria
• Status: Completed
• Phase: Phase 3
• Start date: August 2010
• Completion date: December 2010