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Antioxidant Micronutrients in Malaria

NCT ID: NCT01152931

Last Updated: 2012-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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?

Conditions

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Malaria

Keywords

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Antioxidants Micronutrients Malaria focus is to determine the effect of antioxidant micronutrients in malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Amodiaquine + Artesunate

Intervention Type DRUG

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 + Artesunate

Intervention Type DRUG

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

cohort B= Lumefantrine +Artemether

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

Group Type ACTIVE_COMPARATOR

Lumefantrine + Artemether

Intervention Type DRUG

Lumefantrine and artemether combination will be administered orally at a dose of 120/20mg daily for 3days

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

Group Type EXPERIMENTAL

Artesunate + vitamin A

Intervention Type DIETARY_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 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.

Group Type EXPERIMENTAL

Artesunate + vitamin E

Intervention Type DIETARY_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.

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

Group Type EXPERIMENTAL

Artesunate + Zinc

Intervention Type DIETARY_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

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.

Group Type EXPERIMENTAL

Artesunate + selenium

Intervention Type DIETARY_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

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.

Group Type EXPERIMENTAL

Amodiaquine + vitamin A

Intervention Type DIETARY_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

cohort H = amodiaquine and vitamin E administerd orally

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

Group Type EXPERIMENTAL

Amodiaquine + Vitamin E

Intervention Type DIETARY_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

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.

Group Type EXPERIMENTAL

Amodiaquine + Zinc

Intervention Type DIETARY_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.

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.

Group Type EXPERIMENTAL

Amodiaquine + Selenium

Intervention Type DIETARY_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.

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

Group Type EXPERIMENTAL

Artesunate + vitamin A + vitamin E

Intervention Type DIETARY_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.

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.

Group Type EXPERIMENTAL

Artesunate + Vitamin A + Zinc

Intervention Type DIETARY_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.

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.

Group Type EXPERIMENTAL

Artesunate + Vitamin A + Selenium

Intervention Type DIETARY_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.

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.

Group Type EXPERIMENTAL

Artesunate + Vitamin E + Zinc

Intervention Type DIETARY_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.

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.

Group Type EXPERIMENTAL

Artesunate + Vitamin E + Selenium

Intervention Type DIETARY_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.

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Lumefantrine + Artemether

Lumefantrine and artemether combination will be administered orally at a dose of 120/20mg daily for 3days

Intervention Type DRUG

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

Intervention Type 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.

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lagos, Nigeria

OTHER

Sponsor Role lead

Responsible Party

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Department of Pharmacology and Therapeutics, College of Medicine Ambrose Alli University, Ekpoma.

Principal Investigators

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Osede Ignis Iribhogbe, MB.BS, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Department of Pharmacology and Therapeutics, College of Medicine, Ambrose Alli University, Ekpoma

Ibrahim Oreagba, B.Pharm, M.Sc, Ph.D

Role: STUDY_DIRECTOR

Deparment of Pharmacology, College of Medicine, University of Lagos, Nigeria

Elizabeth O. Agbaje, B.Sc, M.Sc, MPhil, Ph.D

Role: STUDY_CHAIR

Department of Pharmacology, College of Medicine University of Lagos, Nigeria

Prof. Onyebiguwa Patrick NMORSI, PhD, MD

Role: STUDY_DIRECTOR

Dean, Faculty of Natural Sciences Ambrose Alli University Ekpoma

Locations

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Central Primary Health Centre, Ukpenu, Road, Ekpoma.

Ekpoma, Edo, Nigeria

Site Status

Faithdome Medical Centre, Ekpoma.

Ekpoma, Esan West, Edo State, Nigeria

Site Status

Countries

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Nigeria

References

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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.

Reference Type BACKGROUND
PMID: 11431296 (View on PubMed)

Related Links

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http://www.sciencealert.org

chemoprophylactic effect of vitamin C in malaria

Other Identifiers

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ULCT123456

Identifier Type: REGISTRY

Identifier Source: secondary_id

ULCT123456

Identifier Type: REGISTRY

Identifier Source: secondary_id

HCC8/T2A/443111

Identifier Type: REGISTRY

Identifier Source: secondary_id

ULagosclinicaltrials

Identifier Type: -

Identifier Source: org_study_id