Diarrhoea;Infectious;PresumedNCT03012048
Effectiveness of Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in South Africa
A study testing Silver-impregnated ceramic tablet, Silver-impregnated ceramic water filter and Safe-storage water container in people with Diarrhoea;Infectious;Presumed and Diarrhea, Infantile, run by University of Virginia at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diarrhoea;Infectious;Presumed, Diarrhea, Infantile, Diarrhea Tropical
- What is being tested?
- Silver-impregnated ceramic tablet, Silver-impregnated ceramic water filter and Safe-storage water container
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jun 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Low-cost Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in Limpopo, South Africa
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.
Read the 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.
- Conditions
- Diarrhoea;Infectious;Presumed, Diarrhea, Infantile, Diarrhea Tropical, Environmental Exposure, Enteropathy, Malnutrition, Child
- Being tested
- Silver-impregnated ceramic tablet, Silver-impregnated ceramic water filter, Safe-storage water container
- Keywords
- water treatment
- Medical subject headings
- Diarrhea, Infantile, Sprue, Tropical, Intestinal Diseases, Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver-impregnated ceramic tabletDevice
Also called MadiDrop (trade name)
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).
Silver-impregnated ceramic water filterDevice
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).
Safe-storage water containerDevice
The safe-storage water containers used in this study are plastic buckets with a spigot, purchased locally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Silver-impregnated ceramic tablet |
| 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. Receives: Device: Silver-impregnated ceramic water filter |
| Safe-storage water container | Active comparator | Households receive a safe-storage water container alone to use for all drinking water needs in the household. Receives: Device: Safe-storage water container |
| No intervention | No intervention | Households are encouraged to continue their usual water treatment practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in height-for-age z-score (ΔHAZ)
Height measured quarterly among all children under age 15 in the households, z-scores calculated from World Health Organization growth standards
Measured: From 0-2 years of follow-up
Secondary outcomes (5)
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
Measured: From 0-2 years of follow-up
Pathogen burden in stool samples
Non-diarrheal stools collected from the youngest child under 3 years of age in each household; testing for enteroaggregative Escherichia coli, enterohemorrhagic Escherichia coli/EPEC, enterotoxigenic Escherichia coli, Shigella/enteroinvasive Escherichia coli, Giardia, Campylobacter, Cryptosporidium, Adenovirus by quantitative polymerase chain reaction
Measured: Quarterly from 0-2 years of follow-up
Prevalence of diarrhea
7-day recall of diarrhea in the youngest child under 3 years of age in each household
Measured: 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)
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.
Measured: 2, 5, and 7 years of follow-up
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).
Measured: Quarterly from 0-2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJun 2016
- Primary completionDec 2018
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhoea;Infectious;PresumedStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Venda
- Responsible party
- Sponsor
- Investigators
- Pascal O Bessong, PhD, Principal investigator, University of Venda, Limpopo, South AfricaRebecca Dillingham, MD, MPH, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012048
- Sponsor's protocol ID
- IRB-HSR 18662
- Status last verified
- Jul 2025
- First submitted
- 3 Jan 2017
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Low-cost Point-of-use Water Treatment Technologies to Prevent Stunting Among Children in Limpopo, South Africa
- ClinicalTrials.gov ID
- NCT03012048
- Acronym / sponsor ID
- IRB-HSR 18662
- Conditions
- Diarrhoea;Infectious;Presumed, Diarrhea, Infantile, Diarrhea Tropical, Environmental Exposure, Enteropathy, Malnutrition, Child
- Keywords
- water treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University of Venda
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MadiDrop (ceramic tablet) | Experimental | Device: Silver-impregnated ceramic tabletHouseholds 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 | Active comparator | Device: Silver-impregnated ceramic water filterHouseholds 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. |
| Safe-storage water container | Active comparator | Device: Safe-storage water containerHouseholds receive a safe-storage water container alone to use for all drinking water needs in the household. |
| No intervention | No intervention | –Households are encouraged to continue their usual water treatment practices. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver-impregnated ceramic tabletAlso: MadiDrop (trade name)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). | Device | MadiDrop (ceramic tablet) |
| Silver-impregnated ceramic water filterSilver-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). | Device | Silver-impregnated ceramic water filter |
| Safe-storage water containerThe safe-storage water containers used in this study are plastic buckets with a spigot, purchased locally. | Device | Safe-storage water container |
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 World Health Organization growth standards
5 secondary outcomes
Change in weight-for-age z-score (ΔWAZ)
Time frame: From 0-2 years of follow-up
Pathogen burden in stool samples
Time frame: Quarterly from 0-2 years of follow-up
Prevalence of diarrhea
Time frame: 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)
Time frame: 2, 5, and 7 years of follow-up
Silver levels in treated water samples
Time frame: Quarterly from 0-2 years of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Commercial website describing the main experimental device in this trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal O Bessong, PhD principal investigator
University of Venda, Limpopo, South Africa
Rebecca Dillingham, MD, MPH principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver-impregnated ceramic tablet, Silver-impregnated ceramic water filter and Safe-storage water container in people with Diarrhoea;Infectious;Presumed and Diarrhea, Infantile, run by University of Virginia at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in height-for-age z-score (ΔHAZ) (time frame: From 0-2 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.