Antioxidant Micronutrients in Malaria

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Lagos, Nigeria
• Treatments: alpha-Tocopherol; Amodiaquine; Amodiaquine, artesunate drug combination; Antioxidants; Artemether; Artemisinins; Artesunate; Lumefantrine; Micronutrients; Retinol palmitate; Selenium; Tocopherols; Tocotrienols; Trace Elements; Vitamin A; Vitamin E; Vitamins; Zinc

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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