- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01152931
Antioxidant Micronutrients in Malaria (AMM)
Antioxidant Micronutrients in Malaria:a Randomised Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: Amodiaquine + Artesunate
- Drug: Amodiaquine + Artesunate
- Drug: Lumefantrine + Artemether
- Dietary supplement: Artesunate + vitamin A
- Dietary supplement: Artesunate + vitamin E
- Dietary supplement: Artesunate + Zinc
- Dietary supplement: Artesunate + selenium
- Dietary supplement: Amodiaquine + vitamin A
- Dietary supplement: Amodiaquine + Vitamin E
- Dietary supplement: Amodiaquine + Zinc
- Dietary supplement: Amodiaquine + Selenium
- Dietary supplement: Artesunate + vitamin A + vitamin E
- Dietary supplement: Artesunate + Vitamin A + Zinc
- Dietary supplement: Artesunate + Vitamin A + Selenium
- Dietary supplement: Artesunate + Vitamin E + Zinc
- Dietary supplement: Artesunate + Vitamin E + Selenium
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?
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Edo State
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Ekpoma, Edo State, Nigeria, +234
- Central Primary Health Centre, Ukpenu, Road, Ekpoma.
-
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Esan West, Edo State
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Ekpoma, Esan West, Edo State, Nigeria, +234
- Faithdome Medical Centre, Ekpoma.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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
|
Active Comparator: cohort B= Lumefantrine +Artemether
Artemether 20mg/Lumefantrine 120mg fixed combination administered daily for 3 days
|
Lumefantrine and artemether combination will be administered orally at a dose of 120/20mg daily for 3days
|
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
|
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
|
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.
|
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.
|
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
|
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
|
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.
|
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
|
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.
|
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
|
Experimental: cohort H = amodiaquine and vitamin E administerd orally
Amodiaquine 10mg/kg daily for 4 days + vitamin E 100 mg daily 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
|
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.
|
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.
|
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.
|
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.
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-day cure rate
Time Frame: 4 weeks
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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
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Protective Agents
- Trace Elements
- Micronutrients
- Antiprotozoal Agents
- Antiparasitic Agents
- Antioxidants
- Anticarcinogenic Agents
- Antimalarials
- Anthelmintics
- Schistosomicides
- Antiplatyhelmintic Agents
- Vitamin E
- Tocopherols
- alpha-Tocopherol
- Vitamins
- Tocotrienols
- Lumefantrine
- Artemether
- Artesunate
- Amodiaquine
- Selenium
- Zinc
- Vitamin A
- Retinol palmitate
Other Study ID Numbers
- ULagosclinicaltrials
- ULCT123456 (Registry Identifier: Ministry of Health)
- HCC8/T2A/443111 (Registry Identifier: HCC8/T2A/443)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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