Antioxidant Micronutrients in Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 3

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.
    

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. 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?
    

Intervention name(s): Amodiaquine + Artesunate; Amodiaquine + Artesunate; Lumefantrine + Artemether; Artesunate + vitamin A; Artesunate + vitamin E; Artesunate + Zinc; Artesunate + selenium; Amodiaquine + vitamin A; Amodiaquine + Vitamin E; Amodiaquine + Zinc; Amodiaquine + Selenium; Artesunate + vitamin A + vitamin E; Artesunate + Vitamin A + Zinc; Artesunate + Vitamin A + Selenium; Artesunate + Vitamin E + Selenium; Artesunate + Vitamin E + Zinc
Intervention type(s): Drug; Drug; Drug; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Intervention:the intervention in this group involves the use of standard antimalarial therapy for uncomplicated malaria based on WHO recommendation. artemisin based combination therapy will be used. amodiaquine will be administered via the oral route at a dose of 10mg/kg daily while artesunate will be administered orally at Artesunate 100mg stat, 50mg 8hrs later and 50mg bd x 3days; Intervention:the intervention in this group involves the use of standard antimalarial therapy for uncomplicated malaria based on WHO recommendation. artemisinin based combination therapy will be used. amodiaquine will be administered via the oral route at a dose of 10mg/kg daily while artesunate will be administered orally at 100mg stat, 5omg 8hrs later and 50mg 12hrly for 3 days; Lumefantrine and artemether combination will be administered orally at a dose of 120/20mg daily for 3days; Artesunate will be administered orally at a dose of 100mg stat then 50 mg 8hrs later and 50mg 12hrly for 3days. vitamin A will be administered orally at a dose of 2000IU daily for 3 days; Artesunate will be administered orally at 100mg stat, then 50mg 8hrs after and 50mg 12hrly for 3 days. Vitamin E will be administered orally at 100mg dly for 3 days.; Artesunate will be administered orally at a dose of 100mg stat then 50mg 8hrs after and 50mg 12mg 12hrly for 3 days. Zinc gluconate will be administered orally at a dose of 50mg dly for 4 days; Artesunate will be administered orally at 100mg stat and 8hrs later 50mg. then 50mg 12hrly for 3 days. selenium will be administered orally at a dose of 100ug dly for 4 days; Amodiaquine will be administered orally at a dose of 10mg/kg dly for 3days. Vitamin A will be administered orally dly at a dose of 2000IU for 4 days; Amodiaquine will be administered orally at a dose of 10mg/kg dly for 3days. vitamin E will be administered orally at a dose 100mg daily for 4 days; Amodiaquine will be administered orally at a dose of 10mg/kg dly for 3days. Zinc gluconate will be administered orally at a dose of 50mg dly for 4 days.; Amodiaquine will be administered orally at a dose of 10mg/kg daily for 3days. Selenium will be administered orally at a dose of 100ug daily for 4 days if > 1year. 50ug daily for 4 days if < 1 year.; Tab Artesunate 50mg orally daily for 4 days. Vitamin A, 5000IU orally daily for 4days if < 1 year. 10,000 IU orally daily for 4 days if > 1 year.; Tab Artesunate 50 mg daily for 4 days. Vitamin A 5OOOIU daily for 4 days if < 1 year. 10,000IU daily for 4 days if > 1 year. All administered orally.; Tab Artesunate 50 mg orally, daily for 4 days. Vitamin A 5000IU orally daily for 4 days if < 1 year. 10,000IU orally daily for 4 days if > 1 year.; Tab Artesunate 50 mg orally daily for 4 days. Vitamin E 100 mg orally daily for 4 days. Tab selenium 100 ug orally daily for 4 days if > 1 year. 50 ug orally daily for 4 days if < 1 year.; Tab Artesunate administered orally at 50 mg daily for 4 days. Vitamin E 100 mg orally daily for 4 days. Tab Zinc 50 mg orally daily for 4 days if < 1 year. 25 mg orally daily for 4 days if > 1 year.
Intervention MeSH terms: Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol; Vitamin A; Zinc; Selenium; Artesunate; Lumefantrine; Artemether; Amodiaquine; Retinol palmitate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antioxidants; Micronutrients; Malaria; focus is to determine the effect of antioxidant micronutrients in malaria