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临床试验/NCT03012048
NCT03012048已完成不适用

Effectiveness of Low-cost Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in Limpopo, South Africa

University of Virginia2 个研究点 分布在 1 个国家目标入组 415 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
415
试验地点
2
主要终点
Change in height-for-age z-score (ΔHAZ)

研究概览

简要总结

This project is a community-based randomized controlled trial designed to test the effectiveness of two point-of-use water treatment technologies to improve clean drinking water access, reduce enteropathogen burden, and improve child growth among children in Limpopo, South Africa.

详细描述

Lack of access to safe water in low-resource settings likely contributes to stunted growth early in life, which affects more than a quarter of children under 5 years worldwide. Point-of-use water treatment technologies have the potential to provide effective and low-cost solutions to improving quality of drinking water in these settings. One such technology, a silver-impregnated ceramic disk, continually disinfects water in household water storage containers by diffusing silver into the water for daily treatment of 10 to 15 liters for at least six months. Silver-impregnated ceramic water filters are another commercially available technology that additionally remove pathogens mechanically. While both technologies have proven to be highly effective in treating water, it is unknown whether the use of these technologies will translate to improvements in child health outcomes. This community-based intervention trial will estimate the effect of the silver-impregnated ceramic disk and a silver-impregnated ceramic water filter on linear growth of children in Limpopo, South Africa.

Households in the Dzimauli community will be randomized to receive the ceramic disk, a water filter, the safe-storage water container alone, or no intervention. Children will be followed every three months for 2 years to assess height, weight, and pathogen burden in stool samples. Cognitive assessments will be completed at 2, 5, and 7 years of follow-up. The investigators hypothesize that children in households given the ceramic disk or the water filter will show improved linear growth compared to those in households without these interventions. The investigators expect that the ceramic disk will perform similarly to the water filter and result in similar improvements in linear growth when compared to children from control households.

Estimates of effectiveness demonstrated in this trial will provide the necessary evidence base to support the scale-up of manufacturing and distribution of the ceramic disks and filters, which could provide a robust point-of-use water treatment solution for rural areas. By helping to identify effective tools to reduce the risk of stunting in children, the trial will contribute to targets to improve child health in low-resource settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Mother is in third trimester of pregnancy or there is at least one child under 3 years of age in the household
  • The child's caregiver is at least 16 years of age

排除标准

  • The household has chlorinated water piped into the home or routinely delivered (via truck or diversion) to a permanent, engineered system that stores the water within the property
  • The household currently uses a ceramic filter or other commercial water treatment technology (including a permanent, engineered system that treats the water through filtration and/or chlorination)
  • The household has plans to move outside the community in the next 6 months
  • The youngest child under 3 years of age is seriously ill (has a severe disease requiring prolonged hospitalization or a severe or chronic condition diagnosed by medical doctor, e.g. neonatal disease, renal disease, chronic heart failure, liver disease, cystic fibrosis, congenital conditions)

研究组 & 干预措施

MadiDrop (ceramic tablet)

Experimental

Households receive a MadiDrop (silver-impregnated ceramic tablet) in a safe-storage water container to use for all drinking water needs in the household. MadiDrops are replaced every 6 months over the 2-year intervention study period.

In July 2017, all households in the MadiDrop arm were crossed over to the ceramic water filter arm due to inconsistent silver release from the ceramic tablets.

干预措施: Silver-impregnated ceramic tablet (Device)

Silver-impregnated ceramic water filter

Active Comparator

Households receive a silver-impregnated ceramic filter in a safe-storage water container to use for all drinking water needs in the household. Filters are replaced at the end of the 2-year intervention study period.

In December 2017, all silver-impregnated ceramic water filters were replaced with the same ceramic filters without silver due to continued inconsistencies with silver release.

干预措施: Silver-impregnated ceramic water filter (Device)

Safe-storage water container

Active Comparator

Households receive a safe-storage water container alone to use for all drinking water needs in the household.

干预措施: Safe-storage water container (Device)

No intervention

No Intervention

Households are encouraged to continue their usual water treatment practices.

结局指标

主要结局

Change in height-for-age z-score (ΔHAZ)

时间窗: From 0-2 years of follow-up

Height measured quarterly among all children under age 15 in the households, z-scores calculated from World Health Organization growth standards

Change in height-for-age z-score (ΔHAZ)

时间窗: From 0-2 years of follow-up

Height measured quarterly among all children under age 15 in the households, z-scores calculated from World Health Organization growth standards

次要结局

  • Cognitive function - Bayley Scales of Infant Development III (ages 2-3); Wechsler Preschool and Primary Scale of Intelligence III (ages 3-6); Raven's Combined Matrices (ages > 6)(2, 5, and 7 years of follow-up)
  • Change in weight-for-age z-score (ΔWAZ)(From 0-2 years of follow-up)
  • Pathogen burden in stool samples(Quarterly from 0-2 years of follow-up)
  • Prevalence of diarrhea(Quarterly from 0-2 years of follow-up)
  • Silver levels in treated water samples(Quarterly from 0-2 years of follow-up)
  • Prevalence of diarrhea(Quarterly from 0-2 years of follow-up)
  • Change in weight-for-age z-score (ΔWAZ)(From 0-2 years of follow-up)
  • Pathogen burden in stool samples(Quarterly from 0-2 years of follow-up)
  • Cognitive function - Bayley Scales of Infant Development III (ages 2-3); Wechsler Preschool and Primary Scale of Intelligence III (ages 3-6); Raven's Combined Matrices (ages > 6)(2, 5, and 7 years of follow-up)
  • Silver levels in treated water samples(Quarterly from 0-2 years of follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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