Effects of Arachidonic Acid Supplementation on Schistosomiasis Mansoni Infection in Egyptian School Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 335
- 试验地点
- 3
- 主要终点
- Percent egg reduction
研究概览
简要总结
Randomized Controlled Trial:
The investigational materials used in this trial were administered to subjects each day by trained clinicians.
Primary Objectives:
- assess the effect of dietary supplementation with arachidonic acid on the cure rates for Schistosomiasis mansoni with and without concomitant treatment with praziquantel.
- assess the safety of dietary supplementation using arachidonic acid in children with clinically confirmed schistosomiasis mansoni infection.
Secondary objective:
- to measure changes in total phospholipids in plasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consent from parent or legal guardian
- •clinically confirmed schistosomiasis
排除标准
- •not infected with schistosomiasis
- •less than 6 or greater than 15 years of age
研究组 & 干预措施
Praziquantel (PZQ)
A single dose of praziquantel (40 mg/kg) was administered orally on day-1 only, and after 7 days, 1 g of corn oil/soybean oil (50%/50%), for 15 consecutive days of school.
干预措施: Praziquantel (PZQ) (Drug)
Arachidonic acid (ARA)
A single daily dose of 1 g microbial arachidonic acid-rich oil administered orally for 15 consecutive days of school.
干预措施: Arachidonic acid (ARA) (Dietary Supplement)
PZQ + ARA
A single dose of PZQ (40 mg/kg) was administered orally on day-1 only, and after 7 days, followed the next day by 1 g of microbial ARA-rich oil, administered orally as a single dose on 15 consecutive days of school.
干预措施: PZQ+ARA (Dietary Supplement)
结局指标
主要结局
Percent egg reduction
时间窗: 4 weeks after end of 1 day PZQ treatment
Stool samples were collected from each child on three consecutive days to determine egg counts per gram of stool.
次要结局
- Total plasma phospholipids(Three days after 15-day ARA supplementation.)
- Biochemical and hematological parameters(Three days after a 15-day ARA supplementation)