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Antioxidant Micronutrients in Malaria (AMM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01152931
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : May 31, 2012
Sponsor:
Information provided by:
University of Lagos, Nigeria

Tracking Information
First Submitted Date  ICMJE June 28, 2010
First Posted Date  ICMJE June 29, 2010
Last Update Posted Date May 31, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2010)
7-day cure rate [ Time Frame: 4 weeks ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2010)
28-day cure rate. [ Time Frame: 4 weeks ]
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antioxidant Micronutrients in Malaria
Official Title  ICMJE Antioxidant Micronutrients in Malaria:a Randomised Clinical Trial
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?
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malaria
Intervention  ICMJE
  • Drug: Amodiaquine + Artesunate
    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
  • Drug: Amodiaquine + Artesunate
    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
  • Drug: Lumefantrine + Artemether
    Lumefantrine and artemether combination will be administered orally at a dose of 120/20mg daily for 3days
  • Dietary Supplement: Artesunate + vitamin A
    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
  • Dietary Supplement: Artesunate + vitamin E
    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.
  • Dietary Supplement: Artesunate + Zinc
    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
  • Dietary Supplement: Artesunate + selenium
    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
  • Dietary Supplement: Amodiaquine + vitamin A
    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
  • Dietary Supplement: Amodiaquine + Vitamin E
    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
  • Dietary Supplement: Amodiaquine + Zinc
    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.
  • Dietary Supplement: Amodiaquine + Selenium
    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.
  • Dietary Supplement: Artesunate + vitamin A + vitamin E
    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.
  • Dietary Supplement: Artesunate + Vitamin A + Zinc
    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.
  • Dietary Supplement: Artesunate + Vitamin A + Selenium
    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.
  • Dietary Supplement: Artesunate + Vitamin E + Selenium
    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.
  • Dietary Supplement: Artesunate + Vitamin E + Zinc
    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.
Study Arms  ICMJE
  • Active Comparator: COHORT A= Amodiaquine + Artesunate
    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
    Interventions:
    • Drug: Amodiaquine + Artesunate
    • Drug: Amodiaquine + Artesunate
  • Active Comparator: cohort B= Lumefantrine +Artemether
    Artemether 20mg/Lumefantrine 120mg fixed combination administered daily for 3 days
    Intervention: Drug: Lumefantrine + Artemether
  • Experimental: cohort C = Artesunate + vitamin A
    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
    Intervention: Dietary Supplement: Artesunate + vitamin A
  • Experimental: Artesunate, vitamin E oral administration
    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.
    Intervention: Dietary Supplement: Artesunate + vitamin E
  • Experimental: cohort E will be given Artesunate and Zinc orally
    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
    Intervention: Dietary Supplement: Artesunate + Zinc
  • Experimental: cohort F= Artesunate and selenium will be given orally
    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.
    Intervention: Dietary Supplement: Artesunate + selenium
  • Experimental: cohort G = Amodiaqiune and Vitamin A will be given orally
    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.
    Intervention: Dietary Supplement: Amodiaquine + vitamin A
  • Experimental: cohort H = amodiaquine and vitamin E administerd orally
    Amodiaquine 10mg/kg daily for 4 days + vitamin E 100 mg daily for 4 days
    Intervention: Dietary Supplement: Amodiaquine + Vitamin E
  • Experimental: cohort I = Amodiaquine and Zinc will be given orally
    Amodiaquine 10mg/kg daily for 4 days + zinc 50mg daily 4 days. if < 1 year 25 mg daily for 4 days.
    Intervention: Dietary Supplement: Amodiaquine + Zinc
  • Experimental: Cohort J = amodiaquine and selenium will be given orally
    Amodiaquine 10mg/kg daily for 4 days + selenium 100ug daily for 4 days if > 1 year. 50ug daily for 4 days if < 1 year.
    Intervention: Dietary Supplement: Amodiaquine + Selenium
  • Experimental: K= Artesunate+ vitamin A + vitamin E
    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
    Intervention: Dietary Supplement: Artesunate + vitamin A + vitamin E
  • Experimental: L = Artesunate+ Vitamin A + Zinc
    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: Dietary Supplement: Artesunate + Vitamin A + Zinc
  • Experimental: M = Artesunate+ Vitamin A + selenium
    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: Dietary Supplement: Artesunate + Vitamin A + Selenium
  • Experimental: N = Artesunate + Vitamin E + Zinc
    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.
    Intervention: Dietary Supplement: Artesunate + Vitamin E + Zinc
  • Experimental: O = Artesunate+ Vitamin E + Selenium
    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: Dietary Supplement: Artesunate + Vitamin E + Selenium
Publications * Müller 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2010)
10
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2010)
14
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nigeria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01152931
Other Study ID Numbers  ICMJE ULagosclinicaltrials
ULCT123456 ( Registry Identifier: ULCT123456 )
ULCT123456 ( Registry Identifier: Ministry of Health )
HCC8/T2A/443111 ( Registry Identifier: HCC8/T2A/443 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Iribhogbe Osede Ignis, Department of Pharmacology and Therapeutics, College of Medicine Ambrose Alli University, Ekpoma.
Study Sponsor  ICMJE University of Lagos, Nigeria
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Lagos, Nigeria
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP