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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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 effect
Sponsor: University of Virginia

Current Primary Outcome: Change in height-for-age z-score (ΔHAZ) [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in weight-for-age z-score (ΔWAZ) [ Time Frame: 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
  • Pathogen burden in stool samples [ Time Frame: 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 [ Time Frame: 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
  • 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) [ Time Frame: 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 [ Time Frame: 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).


Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: January 3, 2017
Date Started: June 2016
Date Completion: December 2023
Last Updated: January 5, 2017
Last Verified: January 2017