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

Primary Purpose

Diarrhoea;Infectious;Presumed, Diarrhea, Infantile, Diarrhea Tropical

Status
Active
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Silver-impregnated ceramic tablet
Silver-impregnated ceramic water filter
Safe-storage water container
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhoea;Infectious;Presumed focused on measuring water treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Venda

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

MadiDrop (ceramic tablet)

Silver-impregnated ceramic water filter

Safe-storage water container

No intervention

Arm Description

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.

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.

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

Households are encouraged to continue their usual water treatment practices.

Outcomes

Primary Outcome Measures

Change in height-for-age z-score (ΔHAZ)
Height measured quarterly among all children under age 15 in the households, z-scores calculated from WHO growth standards

Secondary Outcome Measures

Change in weight-for-age z-score (ΔWAZ)
Weight measured quarterly among all children under age 15 in the households, z-scores calculated from WHO growth standards
Pathogen burden in stool samples
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
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)
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
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).

Full Information

First Posted
January 3, 2017
Last Updated
May 8, 2018
Sponsor
University of Virginia
Collaborators
University of Venda
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1. Study Identification

Unique Protocol Identification Number
NCT03012048
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
University of Venda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea;Infectious;Presumed, Diarrhea, Infantile, Diarrhea Tropical, Environmental Exposure, Enteropathy, Malnutrition, Child
Keywords
water treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
415 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MadiDrop (ceramic tablet)
Arm Type
Experimental
Arm Description
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.
Arm Title
Silver-impregnated ceramic water filter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Safe-storage water container
Arm Type
Active Comparator
Arm Description
Households receive a safe-storage water container alone to use for all drinking water needs in the household.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Households are encouraged to continue their usual water treatment practices.
Intervention Type
Device
Intervention Name(s)
Silver-impregnated ceramic tablet
Other Intervention Name(s)
MadiDrop (trade name)
Intervention Description
A silver-impregnated ceramic disk used for drinking water treatment that was developed by engineers at the University of Virginia. When the ceramic disk is placed in a household water storage container, silver diffuses through the porous ceramic into the water at a release rate that is effective for continual disinfection of waterborne pathogens while remaining below the silver drinking water standard. The disk is effective for daily treatment of 10 to 15 liters for at least six months. This intervention was removed from the study in July 2017 (approximately at 1 year of follow-up).
Intervention Type
Device
Intervention Name(s)
Silver-impregnated ceramic water filter
Intervention Description
Silver-impregnated ceramic water filter are well-developed, tested, and widely-used devices. In addition to mechanically removing pathogens, the filter is treated with silver to reduce live pathogens that pass through the filter and to provide residual disinfectant to reduce risk of recontamination after treatment. This intervention was replaced with ceramic filters without silver in Dec 2017 (approximately at 1.5 years of follow-up).
Intervention Type
Device
Intervention Name(s)
Safe-storage water container
Intervention Description
The safe-storage water containers used in this study are plastic buckets with a spigot, purchased locally.
Primary Outcome Measure Information:
Title
Change in height-for-age z-score (ΔHAZ)
Description
Height measured quarterly among all children under age 15 in the households, z-scores calculated from WHO growth standards
Time Frame
From 0-2 years of follow-up
Secondary Outcome Measure Information:
Title
Change in weight-for-age z-score (ΔWAZ)
Description
Weight measured quarterly among all children under age 15 in the households, z-scores calculated from WHO growth standards
Time Frame
From 0-2 years of follow-up
Title
Pathogen burden in stool samples
Description
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
Time Frame
Quarterly from 0-2 years of follow-up
Title
Prevalence of diarrhea
Description
7-day recall of diarrhea in the youngest child under 3 years of age in each household
Time Frame
Quarterly from 0-2 years of follow-up
Title
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)
Description
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.
Time Frame
2, 5, and 7 years of follow-up
Title
Silver levels in treated water samples
Description
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).
Time Frame
Quarterly from 0-2 years of follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal O Bessong, PhD
Organizational Affiliation
University of Venda, Limpopo, South Africa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rebecca Dillingham, MD, MPH
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Venda
City
Thohoyandou
State/Province
Limpopo
ZIP/Postal Code
0950
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://madidrop.com/
Description
Commercial website describing the main experimental device in this trial

Learn more about this trial

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

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