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Antioxidant Micronutrients in Malaria (AMM)

Primary Purpose

Malaria

Status
Completed
Phase
Phase 3
Locations
Nigeria
Study Type
Interventional
Intervention
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
Sponsored by
University of Lagos, Nigeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring Antioxidants, Micronutrients, Malaria, focus is to determine the effect of antioxidant micronutrients in malaria

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Primary Health Centre, Ukpenu, Road, Ekpoma.
  • Faithdome Medical Centre, Ekpoma.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

COHORT A= Amodiaquine + Artesunate

cohort B= Lumefantrine +Artemether

cohort C = Artesunate + vitamin A

Artesunate, vitamin E oral administration

cohort E will be given Artesunate and Zinc orally

cohort F= Artesunate and selenium will be given orally

cohort G = Amodiaqiune and Vitamin A will be given orally

cohort H = amodiaquine and vitamin E administerd orally

cohort I = Amodiaquine and Zinc will be given orally

Cohort J = amodiaquine and selenium will be given orally

K= Artesunate+ vitamin A + vitamin E

L = Artesunate+ Vitamin A + Zinc

M = Artesunate+ Vitamin A + selenium

N = Artesunate + Vitamin E + Zinc

O = Artesunate+ Vitamin E + Selenium

Arm Description

Amodiaquine will be administered orally at 10mg/kg daily for 3days. Artesunate 50mg will be administered orally daily for 3days.For subjects >6months< 1 years 4mg/kg daily for 3 days

Artemether 20mg/Lumefantrine 120mg fixed combination administered daily for 3 days

Artesunate 50mg daily for 4days. if >6 months< 1 year 4mg/kg daily for 4days + Vitamin A 5000IU daily for 4days if < 1 year and 10,000IU daily for 4days if > 1 year respectively

Artesunate 50mg daily for 4 days.if >6 months< 1 year 4mg/kg daily for 4 days + vitamin E 100mg daily administered orally to the experimental group 4 days.

cohort E will be given Artesunate 50mg daily for 4 days. if > 6 months< 1 year 4mg/kg daily for 4 days + zinc gluconate 50mg orally daily for 4 days. if < 1 year 25 mg daily for 4 days

Artesunate 50mg daily for 4 days. if > 6 months< 1 year 4mg/kg daily for 4 days + selenium 100ug daily for 4 days. if < 1 year 50ug daily for 4 days.

Amodiaquine 10mg/kg daily for 3 days + vitamin A 5000iu daily for 4 days if < 1 year. 10,000 IU daily for 4 days if > 1 year.

Amodiaquine 10mg/kg daily for 4 days + vitamin E 100 mg daily for 4 days

Amodiaquine 10mg/kg daily for 4 days + zinc 50mg daily 4 days. if < 1 year 25 mg daily for 4 days.

Amodiaquine 10mg/kg daily for 4 days + selenium 100ug daily for 4 days if > 1 year. 50ug daily for 4 days if < 1 year.

Tab Artesunate 50mg orally dly x 4 days + Vitamin A, 5000IU orally, dly x 4 days if ≤ 1yr. 10,000IU orally dly x 4days if > 1 yr + vitamin E 100 mg orally dly for 4 days

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.

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.

Artesunate 50mg daily for 4 days. vitamin E 100mg daily for 4 days. Zinc 50 mg daily for 4 days if > 1 year. 25 mg 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.

Outcomes

Primary Outcome Measures

7-day cure rate
7-day Cure rate will be defined as initial and sustained parasite and symptom clearance with no increase in asexual parasitemia 48 h after the initiation of treatment and the absence of microscopically detected asexual parasitemia within 120 h of the commencement of treatment until day 7

Secondary Outcome Measures

28-day cure rate.
the number of patients with clinical and parasitological cure by day 28 divided by the total number of patients who could be evaluated (per protocol population).

Full Information

First Posted
June 28, 2010
Last Updated
May 30, 2012
Sponsor
University of Lagos, Nigeria
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1. Study Identification

Unique Protocol Identification Number
NCT01152931
Brief Title
Antioxidant Micronutrients in Malaria
Acronym
AMM
Official Title
Antioxidant Micronutrients in Malaria:a Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Lagos, Nigeria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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; Do the micronutrients in question have direct suppressive or schizonticidal effect? Can they be used as short course therapy with standard antimalarials in uncomplicated malaria? Is their effect enhanced when used in combination with each other or with standard antimalarials? Do they have any prophylactic benefit? Can their use alter the course of established malaria infection?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Antioxidants, Micronutrients, Malaria, focus is to determine the effect of antioxidant micronutrients in malaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COHORT A= Amodiaquine + Artesunate
Arm Type
Active Comparator
Arm Description
Amodiaquine will be administered orally at 10mg/kg daily for 3days. Artesunate 50mg will be administered orally daily for 3days.For subjects >6months< 1 years 4mg/kg daily for 3 days
Arm Title
cohort B= Lumefantrine +Artemether
Arm Type
Active Comparator
Arm Description
Artemether 20mg/Lumefantrine 120mg fixed combination administered daily for 3 days
Arm Title
cohort C = Artesunate + vitamin A
Arm Type
Experimental
Arm Description
Artesunate 50mg daily for 4days. if >6 months< 1 year 4mg/kg daily for 4days + Vitamin A 5000IU daily for 4days if < 1 year and 10,000IU daily for 4days if > 1 year respectively
Arm Title
Artesunate, vitamin E oral administration
Arm Type
Experimental
Arm Description
Artesunate 50mg daily for 4 days.if >6 months< 1 year 4mg/kg daily for 4 days + vitamin E 100mg daily administered orally to the experimental group 4 days.
Arm Title
cohort E will be given Artesunate and Zinc orally
Arm Type
Experimental
Arm Description
cohort E will be given Artesunate 50mg daily for 4 days. if > 6 months< 1 year 4mg/kg daily for 4 days + zinc gluconate 50mg orally daily for 4 days. if < 1 year 25 mg daily for 4 days
Arm Title
cohort F= Artesunate and selenium will be given orally
Arm Type
Experimental
Arm Description
Artesunate 50mg daily for 4 days. if > 6 months< 1 year 4mg/kg daily for 4 days + selenium 100ug daily for 4 days. if < 1 year 50ug daily for 4 days.
Arm Title
cohort G = Amodiaqiune and Vitamin A will be given orally
Arm Type
Experimental
Arm Description
Amodiaquine 10mg/kg daily for 3 days + vitamin A 5000iu daily for 4 days if < 1 year. 10,000 IU daily for 4 days if > 1 year.
Arm Title
cohort H = amodiaquine and vitamin E administerd orally
Arm Type
Experimental
Arm Description
Amodiaquine 10mg/kg daily for 4 days + vitamin E 100 mg daily for 4 days
Arm Title
cohort I = Amodiaquine and Zinc will be given orally
Arm Type
Experimental
Arm Description
Amodiaquine 10mg/kg daily for 4 days + zinc 50mg daily 4 days. if < 1 year 25 mg daily for 4 days.
Arm Title
Cohort J = amodiaquine and selenium will be given orally
Arm Type
Experimental
Arm Description
Amodiaquine 10mg/kg daily for 4 days + selenium 100ug daily for 4 days if > 1 year. 50ug daily for 4 days if < 1 year.
Arm Title
K= Artesunate+ vitamin A + vitamin E
Arm Type
Experimental
Arm Description
Tab Artesunate 50mg orally dly x 4 days + Vitamin A, 5000IU orally, dly x 4 days if ≤ 1yr. 10,000IU orally dly x 4days if > 1 yr + vitamin E 100 mg orally dly for 4 days
Arm Title
L = Artesunate+ Vitamin A + Zinc
Arm Type
Experimental
Arm Description
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.
Arm Title
M = Artesunate+ Vitamin A + selenium
Arm Type
Experimental
Arm Description
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.
Arm Title
N = Artesunate + Vitamin E + Zinc
Arm Type
Experimental
Arm Description
Artesunate 50mg daily for 4 days. vitamin E 100mg daily for 4 days. Zinc 50 mg daily for 4 days if > 1 year. 25 mg daily for 4 days if < 1 year.
Arm Title
O = Artesunate+ Vitamin E + Selenium
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Amodiaquine + Artesunate
Intervention Description
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 Type
Drug
Intervention Name(s)
Amodiaquine + Artesunate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lumefantrine + Artemether
Intervention Description
Lumefantrine and artemether combination will be administered orally at a dose of 120/20mg daily for 3days
Intervention Type
Dietary Supplement
Intervention Name(s)
Artesunate + vitamin A
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Artesunate + vitamin E
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Artesunate + Zinc
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Artesunate + selenium
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Amodiaquine + vitamin A
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Amodiaquine + Vitamin E
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Amodiaquine + Zinc
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Amodiaquine + Selenium
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Artesunate + vitamin A + vitamin E
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Artesunate + Vitamin A + Zinc
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Artesunate + Vitamin A + Selenium
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Artesunate + Vitamin E + Selenium
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Artesunate + Vitamin E + Zinc
Intervention Description
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.
Primary Outcome Measure Information:
Title
7-day cure rate
Description
7-day Cure rate will be defined as initial and sustained parasite and symptom clearance with no increase in asexual parasitemia 48 h after the initiation of treatment and the absence of microscopically detected asexual parasitemia within 120 h of the commencement of treatment until day 7
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
28-day cure rate.
Description
the number of patients with clinical and parasitological cure by day 28 divided by the total number of patients who could be evaluated (per protocol population).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osede Ignis Iribhogbe, MB.BS, M.Sc
Organizational Affiliation
Department of Pharmacology and Therapeutics, College of Medicine, Ambrose Alli University, Ekpoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ibrahim Oreagba, B.Pharm, M.Sc, Ph.D
Organizational Affiliation
Deparment of Pharmacology, College of Medicine, University of Lagos, Nigeria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elizabeth O. Agbaje, B.Sc, M.Sc, MPhil, Ph.D
Organizational Affiliation
Department of Pharmacology, College of Medicine University of Lagos, Nigeria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Prof. Onyebiguwa Patrick NMORSI, PhD, MD
Organizational Affiliation
Dean, Faculty of Natural Sciences Ambrose Alli University Ekpoma
Official's Role
Study Director
Facility Information:
Facility Name
Central Primary Health Centre, Ukpenu, Road, Ekpoma.
City
Ekpoma
State/Province
Edo State
ZIP/Postal Code
+234
Country
Nigeria
Facility Name
Faithdome Medical Centre, Ekpoma.
City
Ekpoma
State/Province
Esan West, Edo State
ZIP/Postal Code
+234
Country
Nigeria

12. IPD Sharing Statement

Citations:
PubMed Identifier
11431296
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.
Results Reference
background
Links:
URL
http://www.sciencealert.org
Description
chemoprophylactic effect of vitamin C in malaria

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Antioxidant Micronutrients in Malaria

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