Design and Clinical Evaluation of a School Meal With Deworming Properties
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 326
- 主要终点
- parasite egg count
研究概览
简要总结
Intestinal parasites (IP) are among the world's neglected tropical diseases. Morbidity due to IPs is greatest in school-age children who typically have the highest burden of infection. In 2001, WHO passed a resolution for the use of large-scale mass drug administration (MDA) of antihelminthic drugs to deworm children in developing countries. Though initially effective, there is concern that MDA might not be sustainable over extended periods especially considering the large children populations and the high frequency of dosing. Further, the MDAs exert increasing drug pressure on parasite populations, a circumstance that is likely to favor parasite genotypes that can resist anthelmintic drugs. There is hence a need for alternatives that are not only affordable and sustainable but easier to implement in the long term with a minimal chance of development of resistance. The investigators propose to develop and test the feasibility of a corn porridge meal fortified with papaya fruit extracts that have been shown to have antihelminthic properties. The investigators intend to evaluate its efficacy when given through school feeding programs and compare the outcome with albendazole- the recommended MDA agent for deworming school children. The investigators will design and formulate the product and test it among children in three primary schools in Western Kenya.
详细描述
Background: Soil transmitted helminthes (STHs) are among the world's neglected tropical diseases. Morbidity due to STHs is greatest in school-age children who typically have the highest burden of infection. In 2001, WHO passed a resolution for the use of large-scale mass drug administration (MDA) to deworm vulnerable children. Though effective, there is concern that MDA might not be sustainable over extended periods. Additionally the current MDA strategy do not consider child malnutrition, a very common malady in resource limited countries. The investigators report a pilot evaluation of an innovation that bundles school feeding and deworming.
The investigators designed a maize (corn) flour fortified with grounded dried papaya (Carica papaya) seeds and used it to prepare porridge as per the usual school meal recipe. Children from three primary schools from Nandi County in Kenya were randomized into three arms: One school received 300 ml papaya fortified porridge daily (test school), a second school received similar serving of plain porridge without the pawpaw ingredient (placebo) and a third school received the placebo porridge and the conventional MDA approach of one time 400mg dosage of albendazole. Prior to the randomization, an initial baseline stool microscopy analysis was done to determine presence and intensity of intestinal worms. Core indicators of nutrition-height, weight and hemoglobin counts-were also assessed. The children were monitored daily for two months and final stool sample analysis and clinical monitoring done at the end of the study. Baseline and follow-up data were analyzed and compared through SAS version 9.1 statistical package.
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
- Single (Investigator)
入排标准
- 年龄范围
- 4 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consenting parents and guardians
排除标准
- •children with known allergy to papaya fruit products
研究组 & 干预措施
Papaya seed porridge
Arm receiving porridge fortified with dried papaya seeds (Ujiplus)
干预措施: Ujiplus (Dietary Supplement)
Albendazole and Plain porridge
Arm receiving the approved albendazole treatment of 400mg once with plain porridge daily (without papaya seeds)
干预措施: Albendazole (Drug)
Plain porridge
arm receiving 300ml plain porridge daily (without papaya seeds)
干预措施: uji (Dietary Supplement)
结局指标
主要结局
parasite egg count
时间窗: 60 days after randomization
ova and cyst counts of various helminths in stool sample at end of intervention
次要结局
- Body Mass Index for age(60 days after intervention)
- school attendance(60 days after randomization)
- haemoglobin levels(baseline and after 60 days)
- Number of children with tinea capitis(60 days after randomization)
研究者
Elijah M. Songok
Prof. Elijah M. Songok
Kenya Medical Research Institute
