Antioxidant Micronutrients in Malaria
AMM
3 other identifiers
interventional
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2010
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMay 31, 2012
August 1, 2010
3 months
June 28, 2010
May 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
4 weeks
Secondary Outcomes (1)
28-day cure rate.
4 weeks
Study Arms (15)
COHORT A= Amodiaquine + Artesunate
ACTIVE COMPARATORAmodiaquine 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
cohort B= Lumefantrine +Artemether
ACTIVE COMPARATORArtemether 20mg/Lumefantrine 120mg fixed combination administered daily for 3 days
cohort C = Artesunate + vitamin A
EXPERIMENTALArtesunate 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, vitamin E oral administration
EXPERIMENTALArtesunate 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 and Zinc orally
EXPERIMENTALcohort 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
cohort F= Artesunate and selenium will be given orally
EXPERIMENTALArtesunate 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.
cohort G = Amodiaqiune and Vitamin A will be given orally
EXPERIMENTALAmodiaquine 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.
cohort H = amodiaquine and vitamin E administerd orally
EXPERIMENTALAmodiaquine 10mg/kg daily for 4 days + vitamin E 100 mg daily for 4 days
cohort I = Amodiaquine and Zinc will be given orally
EXPERIMENTALAmodiaquine 10mg/kg daily for 4 days + zinc 50mg daily 4 days. if \< 1 year 25 mg daily for 4 days.
Cohort J = amodiaquine and selenium will be given orally
EXPERIMENTALAmodiaquine 10mg/kg daily for 4 days + selenium 100ug daily for 4 days if \> 1 year. 50ug daily for 4 days if \< 1 year.
K= Artesunate+ vitamin A + vitamin E
EXPERIMENTALTab 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
L = Artesunate+ Vitamin A + Zinc
EXPERIMENTALTab 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.
M = Artesunate+ Vitamin A + selenium
EXPERIMENTALArtesunate 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.
N = Artesunate + Vitamin E + Zinc
EXPERIMENTALArtesunate 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.
O = Artesunate+ Vitamin E + Selenium
EXPERIMENTALTab 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Central Primary Health Centre, Ukpenu, Road, Ekpoma.
Ekpoma, Edo, +234, Nigeria
Faithdome Medical Centre, Ekpoma.
Ekpoma, Esan West, Edo State, +234, Nigeria
Related Publications (1)
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.
PMID: 11431296BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Osede Ignis Iribhogbe, MB.BS, M.Sc
Department of Pharmacology and Therapeutics, College of Medicine, Ambrose Alli University, Ekpoma
- STUDY DIRECTOR
Ibrahim Oreagba, B.Pharm, M.Sc, Ph.D
Deparment of Pharmacology, College of Medicine, University of Lagos, Nigeria
- STUDY CHAIR
Elizabeth O. Agbaje, B.Sc, M.Sc, MPhil, Ph.D
Department of Pharmacology, College of Medicine University of Lagos, Nigeria
- STUDY DIRECTOR
Prof. Onyebiguwa Patrick NMORSI, PhD, MD
Dean, Faculty of Natural Sciences Ambrose Alli University Ekpoma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 28, 2010
First Posted
June 29, 2010
Study Start
August 1, 2010
Primary Completion
November 1, 2010
Study Completion
December 1, 2010
Last Updated
May 31, 2012
Record last verified: 2010-08