NCT03012048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

January 3, 2017

Last Update Submit

July 10, 2025

Conditions

Keywords

water treatment

Outcome Measures

Primary Outcomes (1)

  • 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

    From 0-2 years of follow-up

Secondary Outcomes (5)

  • Change in weight-for-age z-score (ΔWAZ)

    From 0-2 years of follow-up

  • Pathogen burden in stool samples

    Quarterly from 0-2 years of follow-up

  • Prevalence of diarrhea

    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)

    2, 5, and 7 years of follow-up

  • Silver levels in treated water samples

    Quarterly from 0-2 years of follow-up

Study Arms (4)

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.

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.

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.

Device: Safe-storage water container

No intervention

NO INTERVENTION

Households are encouraged to continue their usual water treatment practices.

Interventions

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).

Also known as: MadiDrop (trade name)
MadiDrop (ceramic tablet)

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).

Silver-impregnated ceramic water filter

The safe-storage water containers used in this study are plastic buckets with a spigot, purchased locally.

Safe-storage water container

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Venda

Thohoyandou, Limpopo, 0950, South Africa

Location

Related Links

MeSH Terms

Conditions

Diarrhea, InfantileSprue, TropicalIntestinal DiseasesChild Nutrition Disorders

Condition Hierarchy (Ancestors)

DiarrheaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMalabsorption SyndromesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesNutrition Disorders

Study Officials

  • Pascal O Bessong, PhD

    University of Venda, Limpopo, South Africa

    PRINCIPAL INVESTIGATOR
  • Rebecca Dillingham, MD, MPH

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 6, 2017

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations