MalariaPhase 3AMMNCT01152931
Antioxidant Micronutrients in Malaria
A Phase 3 study testing Amodiaquine + Artesunate, Lumefantrine + Artemether and Artesunate + vitamin A in people with Malaria, run by University of Lagos, Nigeria at 2 sites in Nigeria.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Malaria
- What is being tested?
- Amodiaquine + Artesunate, Lumefantrine + Artemether and Artesunate + vitamin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesNigeria
- Study dates
- Aug 2010to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Nigeria2 sites
Central Primary Health Centre, Ukpenu, Road, Ekpoma.
Ekpoma, Edo, +234
Faithdome Medical Centre, Ekpoma.
Ekpoma, Esan West, Edo State, +234
About this study
Official title: Antioxidant Micronutrients in Malaria:a Randomised Clinical Trial
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.
Read the 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?
- Conditions
- Malaria
- Being tested
- Amodiaquine + Artesunate, Lumefantrine + Artemether, Artesunate + vitamin A, Artesunate + vitamin E, Artesunate + Zinc
- Keywords
- Antioxidants, Micronutrients, Malaria, focus is to determine the effect of antioxidant micronutrients in malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amodiaquine + ArtesunateDrug
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
Amodiaquine + ArtesunateDrug
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
Lumefantrine + ArtemetherDrug
Lumefantrine and artemether combination will be administered orally at a dose of 120/20mg daily for 3days
Artesunate + vitamin ADietary supplement
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 + vitamin EDietary supplement
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 + ZincDietary supplement
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 + seleniumDietary supplement
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 + vitamin ADietary supplement
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 + Vitamin EDietary supplement
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 + ZincDietary supplement
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 + SeleniumDietary supplement
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.
Artesunate + vitamin A + vitamin EDietary supplement
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.
Artesunate + Vitamin A + ZincDietary supplement
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 + Vitamin A + SeleniumDietary supplement
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.
Artesunate + Vitamin E + SeleniumDietary supplement
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.
Artesunate + Vitamin E + ZincDietary supplement
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 group | Role | What they receive |
|---|---|---|
| COHORT A= Amodiaquine + Artesunate | Active comparator | 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 Receives: Drug: Amodiaquine + Artesunate |
| cohort B= Lumefantrine +Artemether | Active comparator | Artemether 20mg/Lumefantrine 120mg fixed combination administered daily for 3 days Receives: Drug: Lumefantrine + Artemether |
| cohort C = Artesunate + vitamin A | Experimental | 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 Receives: Dietary Supplement: Artesunate + vitamin A |
| Artesunate, vitamin E oral administration | Experimental | 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. Receives: Dietary Supplement: Artesunate + vitamin E |
| cohort E will be given Artesunate and Zinc orally | Experimental | 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 Receives: Dietary Supplement: Artesunate + Zinc |
| cohort F= Artesunate and selenium will be given orally | Experimental | 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. Receives: Dietary Supplement: Artesunate + selenium |
| cohort G = Amodiaqiune and Vitamin A will be given orally | Experimental | 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. Receives: Dietary Supplement: Amodiaquine + vitamin A |
| cohort H = amodiaquine and vitamin E administerd orally | Experimental | Amodiaquine 10mg/kg daily for 4 days + vitamin E 100 mg daily for 4 days Receives: Dietary Supplement: Amodiaquine + Vitamin E |
| cohort I = Amodiaquine and Zinc will be given orally | Experimental | Amodiaquine 10mg/kg daily for 4 days + zinc 50mg daily 4 days. if < 1 year 25 mg daily for 4 days. Receives: Dietary Supplement: Amodiaquine + Zinc |
| Cohort J = amodiaquine and selenium will be given orally | Experimental | Amodiaquine 10mg/kg daily for 4 days + selenium 100ug daily for 4 days if > 1 year. 50ug daily for 4 days if < 1 year. Receives: Dietary Supplement: Amodiaquine + Selenium |
| K= Artesunate+ vitamin A + vitamin E | Experimental | 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 Receives: Dietary Supplement: Artesunate + vitamin A + vitamin E |
| L = Artesunate+ Vitamin A + Zinc | Experimental | 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. Receives: Dietary Supplement: Artesunate + Vitamin A + Zinc |
| M = Artesunate+ Vitamin A + selenium | Experimental | 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. Receives: Dietary Supplement: Artesunate + Vitamin A + Selenium |
| N = Artesunate + Vitamin E + Zinc | Experimental | 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. Receives: Dietary Supplement: Artesunate + Vitamin E + Zinc |
| O = Artesunate+ Vitamin E + Selenium | Experimental | 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. Receives: Dietary Supplement: Artesunate + Vitamin E + Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (1)
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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lagos, Nigeria
- Sponsor type
- University, hospital or other
- Investigators
- Osede Ignis Iribhogbe, MB.BS, M.Sc, Principal investigator, Department of Pharmacology and Therapeutics, College of Medicine, Ambrose Alli University, EkpomaIbrahim Oreagba, B.Pharm, M.Sc, Ph.D, Study director, Deparment of Pharmacology, College of Medicine, University of Lagos, NigeriaElizabeth O. Agbaje, B.Sc, M.Sc, MPhil, Ph.D, Study chair, Department of Pharmacology, College of Medicine University of Lagos, NigeriaProf. Onyebiguwa Patrick NMORSI, PhD, MD, Study director, Dean, Faculty of Natural Sciences Ambrose Alli University Ekpoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152931
- Sponsor's protocol ID
- ULagosclinicaltrials
- Other IDs
- ULCT123456, ULCT123456, HCC8/T2A/443111
- Acronym
- AMM
- Status last verified
- Aug 2010
- First submitted
- 28 Jun 2010
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11431296
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant Micronutrients in Malaria:a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01152931
- Acronym / sponsor ID
- AMM / ULagosclinicaltrials
- Conditions
- Malaria
- Keywords
- Antioxidants, Micronutrients, Malaria, focus is to determine the effect of antioxidant micronutrients in malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Lagos, NigeriaUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| COHORT A= Amodiaquine + Artesunate | Active comparator | Drug: Amodiaquine + ArtesunateAmodiaquine 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 comparator | Drug: Lumefantrine + ArtemetherArtemether 20mg/Lumefantrine 120mg fixed combination administered daily for 3 days |
| cohort C = Artesunate + vitamin A | Experimental | Dietary Supplement: Artesunate + vitamin AArtesunate 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 | Experimental | Dietary Supplement: Artesunate + vitamin EArtesunate 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 | Experimental | Dietary Supplement: Artesunate + Zinccohort 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 | Experimental | Dietary Supplement: Artesunate + seleniumArtesunate 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 | Experimental | Dietary Supplement: Amodiaquine + vitamin AAmodiaquine 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 | Experimental | Dietary Supplement: Amodiaquine + Vitamin EAmodiaquine 10mg/kg daily for 4 days + vitamin E 100 mg daily for 4 days |
| cohort I = Amodiaquine and Zinc will be given orally | Experimental | Dietary Supplement: Amodiaquine + ZincAmodiaquine 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 | Experimental | Dietary Supplement: Amodiaquine + SeleniumAmodiaquine 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 | Experimental | Dietary Supplement: Artesunate + vitamin A + vitamin ETab 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 | Experimental | Dietary Supplement: Artesunate + Vitamin A + ZincTab 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 | Experimental | Dietary Supplement: Artesunate + Vitamin A + SeleniumArtesunate 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 | Experimental | Dietary Supplement: Artesunate + Vitamin E + ZincArtesunate 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 | Experimental | Dietary Supplement: Artesunate + Vitamin E + SeleniumTab 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. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- adequate antimalarial treatment within the previous 7 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amodiaquine + ArtesunateIntervention: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 | COHORT A= Amodiaquine + Artesunate |
| Amodiaquine + ArtesunateIntervention: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 | COHORT A= Amodiaquine + Artesunate |
| Lumefantrine + ArtemetherLumefantrine and artemether combination will be administered orally at a dose of 120/20mg daily for 3days | Drug | cohort B= Lumefantrine +Artemether |
| Artesunate + vitamin AArtesunate 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 | cohort C = Artesunate + vitamin A |
| Artesunate + vitamin EArtesunate 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, vitamin E oral administration |
| Artesunate + ZincArtesunate 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 | cohort E will be given Artesunate and Zinc orally |
| Artesunate + seleniumArtesunate 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 | cohort F= Artesunate and selenium will be given orally |
| Amodiaquine + vitamin AAmodiaquine 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 | cohort G = Amodiaqiune and Vitamin A will be given orally |
| Amodiaquine + Vitamin EAmodiaquine 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 | cohort H = amodiaquine and vitamin E administerd orally |
| Amodiaquine + ZincAmodiaquine 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 | cohort I = Amodiaquine and Zinc will be given orally |
| Amodiaquine + SeleniumAmodiaquine 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 | Cohort J = amodiaquine and selenium will be given orally |
| Artesunate + vitamin A + vitamin ETab 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 | K= Artesunate+ vitamin A + vitamin E |
| Artesunate + Vitamin A + ZincTab 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 | L = Artesunate+ Vitamin A + Zinc |
| Artesunate + Vitamin A + SeleniumTab 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 | M = Artesunate+ Vitamin A + selenium |
| Artesunate + Vitamin E + SeleniumTab 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 | O = Artesunate+ Vitamin E + Selenium |
| Artesunate + Vitamin E + ZincTab 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. | Dietary supplement | N = Artesunate + Vitamin E + Zinc |
Primary outcome
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
1 secondary outcome
28-day cure rate.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2012.
- Background: PubMed 11431296Muller 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.
- chemoprophylactic effect of vitamin C in malariaLink provided by the sponsor.
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Malaria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osede Ignis Iribhogbe, MB.BS, M.Sc principal investigator
Department of Pharmacology and Therapeutics, College of Medicine, Ambrose Alli University, Ekpoma
Ibrahim Oreagba, B.Pharm, M.Sc, Ph.D study director
Deparment of Pharmacology, College of Medicine, University of Lagos, Nigeria
Elizabeth O. Agbaje, B.Sc, M.Sc, MPhil, Ph.D study chair
Department of Pharmacology, College of Medicine University of Lagos, Nigeria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amodiaquine + Artesunate, Lumefantrine + Artemether and Artesunate + vitamin A in people with Malaria, run by University of Lagos, Nigeria at 2 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day cure rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01152931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2012.