Clinical trial NCT03012048: Effectiveness of Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in South Africa
Official title: Effectiveness of Low-cost Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in Limpopo, South Africa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diarrhoea;Infectious;Presumed
Diarrhea, Infantile
Diarrhea Tropical
Environmental Exposure
Enteropathy
Malnutrition, Child
Keywords: water treatment
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: University of Venda
First posted: 2017-01-06
Enrollment: 415
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

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)

Primary outcomes:
measure: Change in height-for-age z-score (ΔHAZ)
timeFrame: From 0-2 years of follow-up
Secondary outcomes:
measure: Change in weight-for-age z-score (ΔWAZ)
timeFrame: From 0-2 years of follow-up
measure: Pathogen burden in stool samples
timeFrame: Quarterly from 0-2 years of follow-up
measure: Prevalence of diarrhea
timeFrame: Quarterly from 0-2 years of follow-up
measure: 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)
timeFrame: 2, 5, and 7 years of follow-up
measure: Silver levels in treated water samples
timeFrame: Quarterly from 0-2 years of follow-up
Other outcomes:
Locations:
city: Thohoyandou
country: South Africa
facility: University of Venda
state: Limpopo
Study officials:
affiliation: University of Venda, Limpopo, South Africa
name: Pascal O Bessong, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Rebecca Dillingham, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: