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临床试验/NCT02725255
NCT02725255已完成2 期

Design and Clinical Evaluation of a School Meal With Deworming Properties

Kenya Medical Research Institute0 个研究点目标入组 326 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Arm receiving porridge fortified with dried papaya seeds (Ujiplus)

干预措施: Ujiplus (Dietary Supplement)

Albendazole and Plain porridge

Active Comparator

Arm receiving the approved albendazole treatment of 400mg once with plain porridge daily (without papaya seeds)

干预措施: Albendazole (Drug)

Plain porridge

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elijah M. Songok

Prof. Elijah M. Songok

Kenya Medical Research Institute

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