Antioxidant Micronutrients in Malaria:a Randomised Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- 7-day cure rate
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Amodiaquine + Artesunate (Drug)
cohort B= Lumefantrine +Artemether
Artemether 20mg/Lumefantrine 120mg fixed combination administered daily for 3 days
干预措施: Lumefantrine + Artemether (Drug)
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
干预措施: Artesunate + vitamin A (Dietary Supplement)
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.
干预措施: Artesunate + vitamin E (Dietary Supplement)
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
干预措施: Artesunate + Zinc (Dietary Supplement)
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.
干预措施: Artesunate + selenium (Dietary Supplement)
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.
干预措施: Amodiaquine + vitamin A (Dietary Supplement)
cohort H = amodiaquine and vitamin E administerd orally
Amodiaquine 10mg/kg daily for 4 days + vitamin E 100 mg daily for 4 days
干预措施: Amodiaquine + Vitamin E (Dietary Supplement)
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.
干预措施: Amodiaquine + Zinc (Dietary Supplement)
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.
干预措施: Amodiaquine + Selenium (Dietary Supplement)
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
干预措施: Artesunate + vitamin A + vitamin E (Dietary Supplement)
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.
干预措施: Artesunate + Vitamin A + Zinc (Dietary Supplement)
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.
干预措施: Artesunate + Vitamin A + Selenium (Dietary Supplement)
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.
干预措施: Artesunate + Vitamin E + Zinc (Dietary Supplement)
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.
干预措施: Artesunate + Vitamin E + Selenium (Dietary Supplement)
结局指标
主要结局
7-day cure rate
时间窗: 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
次要结局
- 28-day cure rate.(4 weeks)