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

Not Applicable

• Conditions: Diarrhoea;Infectious;Presumed; Diarrhea Tropical; Environmental Exposure; Diarrhea, Infantile; Enteropathy; Malnutrition, Child
• Interventions: Device: Safe-storage water container; Device: Silver-impregnated ceramic tablet; Device: Silver-impregnated ceramic water filter

• Registration Number: NCT03012048
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-14
• Primary Completion: 2018-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 415

Inclusion Criteria

• 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

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Safe-storage water container	Safe-storage water container	Households receive a safe-storage water container alone to use for all drinking water needs in the household.
MadiDrop (ceramic tablet)	Silver-impregnated ceramic tablet	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.
Silver-impregnated ceramic water filter	Silver-impregnated ceramic water filter	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.

Primary Outcome Measures

Name	Time	Method
Change in height-for-age z-score (ΔHAZ)	From 0-2 years of follow-up	Height measured quarterly among all children under age 15 in the households, z-scores calculated from WHO growth standards

Secondary Outcome Measures

Name	Time	Method
Change in weight-for-age z-score (ΔWAZ)	From 0-2 years of follow-up	Weight measured quarterly among all children under age 15 in the households, z-scores calculated from WHO growth standards
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	Cognitive assessments will be completed for the youngest child in each household (determined at enrollment) using age-appropriate developmental tests that have already been adapted, translated, and piloted in this population. Caregivers will be asked to bring their child to the local health clinic to be assessed by a Psychological Research Assistant.
Silver levels in treated water samples	Quarterly from 0-2 years of follow-up	Treated water samples will be taken from a random subset of 50 households receiving the filter or ceramic disk every three months to determine the silver levels in treated water from the households. Total silver concentration will be measured by graphite furnace atomic absorption spectrometry (U.S.E.P.A. Method 7010).
Pathogen burden in stool samples	Quarterly from 0-2 years of follow-up	Non-diarrheal stools collected from the youngest child under 3 years of age in each household; testing for EAEC, EHEC/EPEC, ETEC, Shigella/EIEC, Giardia, Campylobacter, Cryptosporidium, Adenovirus by qPCR
Prevalence of diarrhea	Quarterly from 0-2 years of follow-up	7-day recall of diarrhea in the youngest child under 3 years of age in each household

Trial Locations

Locations (1)

University of Venda; 🇿🇦 Thohoyandou, Limpopo, South Africa