Antioxidant Micronutrients in Malaria

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.

Conditions

• Malaria

Interventions

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.

Sponsors & Collaborators

• University of Lagos, Nigeria

  lead OTHER

Principal Investigators

• Osede Ignis Iribhogbe, MB.BS, M.Sc · Department of Pharmacology and Therapeutics, College of Medicine, Ambrose Alli University, Ekpoma

• Ibrahim Oreagba, B.Pharm, M.Sc, Ph.D · Deparment of Pharmacology, College of Medicine, University of Lagos, Nigeria

• Elizabeth O. Agbaje, B.Sc, M.Sc, MPhil, Ph.D · Department of Pharmacology, College of Medicine University of Lagos, Nigeria

• Prof. Onyebiguwa Patrick NMORSI, PhD, MD · Dean, Faculty of Natural Sciences Ambrose Alli University Ekpoma

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Months

Max Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2010-11-30

Completion

2010-12-31

Countries

• Nigeria

Study Locations