Skip to main content
OpenTrials
Completed

NCT Number: NCT02606981

Automatic Chlorination and Child Health in Urban Bangladesh

Municipal water networks within industrialized countries typically rely on centralized treatment to manage piped water quality. Optimal water quality at the tap, however, requires well-maintained piped distribution networks, and performs best when piped systems are fully pressurized. In low-income cities such as Dhaka, water distribution networks are inadequately maintained and typically supply intermittent service; as such, they are vulnerable to recontamination during negative pressure events. Among populations accessing these types of improved water sources in urban settings (e.g. shared taps), it is unknown if consistent treatment to provide chlorinated water at the point of collection would have a significant health benefit. Furthermore, almost all previous studies of water treatment interventions in low-income countries have been unblinded with self-reported diarrhea as the main outcome, casting doubt that reported impacts of water disinfection on diarrhea are not due entirely to social desirability bias. Stanford University in collaboration with icddr,b will conduct a randomized evaluation to assess the impact on access to automatically chlorinated water on water quality and child health.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diarrhea Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

Up to 60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongi and Dhaka Uddan

Tongi/Dhaka, Gazipur, Bangladesh

About this study

Investigators will conduct a blinded cluster randomized controlled trial to evaluate the health and economic impacts of having access to automatically chlorinated water. The unit of randomization will be shared water points that typically serve 20-200 households. Shared water points connected to holding tanks compatible with the water treatment technology, and serving more than 4 households with at least one child under five, will be identified. Households accessing eligible water points as their primary drinking water source will be enrolled before installation of chlorine devices, and a baseline survey will be conducted of water quality, diarrhea prevalence, and health care expenditures. Following this baseline, households will be randomly assigned to control or treatment groups. The chlorination devices will be installed at the treatment group water points, while a doser containing vitamin C (and no chlorine), will be installed in the control group. The free chlorine dosing target will be below <1ppm to preserve blinding. All households will be surveyed every 2-3 months for a total follow up period of 14-16 months (5-7 survey rounds, budget permitting).

Objectives:

  • To evaluate the impact of an automated chlorination system on microbial stored drinking water quality, residual chlorine, user satisfaction, user perceptions of water taste and smell, under-five child diarrhea (longitudinal prevalence) compared to a control group.
  • Compare the marginal additional cost (per person served) of installing and maintaining an automated chlorination system integrated with the current water supply infrastructure in low-income areas of Dhaka.
  • Assess the impact of an automated chlorination system on hospital visits and health care expenditures.
  • To measure secondary outcomes of the impact of an automated chlorination system including under-five child weight-for-age (WAZ), under-five height-for-age (HAZ), as well as levels of C-reactive protein and immunoglobin G in serum samples collected from children under five (these are objective indicators of infection, such as repeat diarrheal episodes).

Analysis:

The primary analyses will be intent-to-treat (investigators will analyze differences in outcomes between the treatment and control groups, with groups defined by their random allocation). Investigators will also conduct a secondary analysis comparing outcomes between intervention and control, where the intervention group is defined as those households that had free chlorine residual detected in their stored drinking water (treated on the treated analysis).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Households with at least one child under 60 months old
  • Households using enrolled shared water point as primary drinking water source

Exclusion criteria

  • Households with a private drinking water source

Note: New births and children under 60 months that migrate into compounds accessing the enrolled water points for drinking water will be enrolled into the study.

Treatment and study plan

Water chlorination by the Flogenic

Device

The chlorine doser delivers a constant amount of chlorine into water as it flows into a holding tank. The water is then piped to public and private taps.

Other names: Flogenic by Medentech

Active control, vitamin C dosing into water

Device

The control group will receive a vitamin C dosing device that looks identical to the intervention chlorine doser installed in the holding tank that feeds their shared water access point.

Other names: Vitamin C dosing device (not commercially available)

Primary outcomes

  1. Diarrhea longitudinal prevalence

    Time frame: Measured every 2-3 months for 16 months post baseline

    1-week recall period, case definition is 3 or more loose/watery bowel movements in 24 hours

Secondary outcomes

  1. Weight-for-age-z-score

    Time frame: Measured every 2-3 months for 16 months post baseline

    Weight-for-age z-score among children under five years

  2. Height-for-age-z-score

    Time frame: Measured at baseline and 16 months after baseline

    Height-for-age z-score among children under five

  3. Respiratory illness longitudinal prevalence

    Time frame: Measured every 2-3 months for 16 months post baseline

    one week recall period, symptoms include congestion, cough, difficulty breathing

  4. C-reactive protein

    Time frame: Measured at baseline and conclusion of study (16 months post baseline) among children under five

  5. total immunoglobin G (IgG)

    Time frame: Measured at baseline and conclusion of study (16 months post baseline) among children under five

  6. Prevalence and number of enteric pathogens

    Time frame: Measured 6-12 months after intervention delivery among children under five

  7. Caregiver defined diarrhea

    Time frame: Measured every 2-3 months for 16 months post baseline

    1-week recall period, defined with local Bengali word for diarrhea

Other outcomes

  1. Microbial water quality

    Time frame: Measured monthly among a subset of households, for 16 months post baseline

    Colony forming units of the fecal indicator bacteria, E. coli

  2. Chlorine residual in household stored drinking water

    Time frame: Measured every 2-3 months for 16 months post baseline

    Free chlorine residual in ppm

  3. health related treatment and associated cost

    Time frame: Measured every 2-3 months for 16 months post baseline

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

Registry information

Official study title

Evaluating Low-cost Automatic Water Disinfection Systems to Improve Water Quality and Child Health in Urban Bangladesh

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2015
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.