Clinical trial NCT01152931: Antioxidant Micronutrients in Malaria
Official title: Antioxidant Micronutrients in Malaria:a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: Antioxidants
Micronutrients
Malaria
focus is to determine the effect of antioxidant micronutrients in malaria
Lead sponsor: University of Lagos, Nigeria
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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?

Eligibility 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

Primary outcomes:
measure: 7-day cure rate
timeFrame: 4 weeks
Secondary outcomes:
measure: 28-day cure rate.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ekpoma
country: Nigeria
facility: Central Primary Health Centre, Ukpenu, Road, Ekpoma.
state: Edo State
city: Ekpoma
country: Nigeria
facility: Faithdome Medical Centre, Ekpoma.
state: Esan West, Edo State
Study officials:
affiliation: Department of Pharmacology and Therapeutics, College of Medicine, Ambrose Alli University, Ekpoma
name: Osede Ignis Iribhogbe, MB.BS, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Deparment of Pharmacology, College of Medicine, University of Lagos, Nigeria
name: Ibrahim Oreagba, B.Pharm, M.Sc, Ph.D
role: STUDY_DIRECTOR
affiliation: Department of Pharmacology, College of Medicine University of Lagos, Nigeria
name: Elizabeth O. Agbaje, B.Sc, M.Sc, MPhil, Ph.D
role: STUDY_CHAIR
affiliation: Dean, Faculty of Natural Sciences Ambrose Alli University Ekpoma
name: Prof. Onyebiguwa Patrick NMORSI, PhD, MD
role: STUDY_DIRECTOR
References:
citation: Muller O, Becher H, van Zweeden AB, Ye Y, Diallo DA, Konate AT, Gbangou A, Kouyate B, Garenne M. Effect of zinc supplementation on malaria and other causes of morbidity in west African children: randomised double blind placebo controlled trial. BMJ. 2001 Jun 30;322(7302):1567. doi: 10.1136/bmj.322.7302.1567.