Automatic Chlorination and Child Health in Urban Bangladesh

Evaluating Low-cost Automatic Water Disinfection Systems to Improve Water Quality 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.

Study Overview

• Status: Completed
• Conditions: Communicable Diseases; Diarrhea
• Intervention / Treatment: Device: Water chlorination by the Flogenic; Device: Active control, vitamin C dosing into water

Detailed Description

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:

1. 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.
2. 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.
3. Assess the impact of an automated chlorination system on hospital visits and health care expenditures.
4. 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).

• Study Type: Interventional
• Enrollment (Actual): 1549
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Gazipur
    • Tongi/Dhaka, Gazipur, Bangladesh
      • Tongi and Dhaka Uddan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Chlorination; Device: Water chlorination by the Flogenic Primary drinking water source will be outfitted with automatic dosing device supplied with chlorine tablets. The device is called the Flogenic.	Device: Water chlorination by the Flogenic; 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
PLACEBO_COMPARATOR: Control; Active control: Vitamin C dosing into water. Primary drinking water source will be outfitted with automatic dosing device supplied with vitamin C tablets. The device is not commercially available.	Device: Active control, vitamin C dosing into water; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diarrhea longitudinal prevalence	1-week recall period, case definition is 3 or more loose/watery bowel movements in 24 hours	Measured every 2-3 months for 16 months post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight-for-age-z-score	Weight-for-age z-score among children under five years	Measured every 2-3 months for 16 months post baseline
Height-for-age-z-score	Height-for-age z-score among children under five	Measured at baseline and 16 months after baseline
Respiratory illness longitudinal prevalence	one week recall period, symptoms include congestion, cough, difficulty breathing	Measured every 2-3 months for 16 months post baseline
C-reactive protein		Measured at baseline and conclusion of study (16 months post baseline) among children under five
total immunoglobin G (IgG)		Measured at baseline and conclusion of study (16 months post baseline) among children under five
Prevalence and number of enteric pathogens		Measured 6-12 months after intervention delivery among children under five
Caregiver defined diarrhea	1-week recall period, defined with local Bengali word for diarrhea	Measured every 2-3 months for 16 months post baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial water quality	Colony forming units of the fecal indicator bacteria, E. coli	Measured monthly among a subset of households, for 16 months post baseline
Chlorine residual in household stored drinking water	Free chlorine residual in ppm	Measured every 2-3 months for 16 months post baseline
health related treatment and associated cost		Measured every 2-3 months for 16 months post baseline

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh
• Investigators: Study Director: Amy Pickering, PhD, Stanford University

Publications and helpful links

General Publications

• Pickering AJ, Crider Y, Sultana S, Swarthout J, Goddard FG, Anjerul Islam S, Sen S, Ayyagari R, Luby SP. Effect of in-line drinking water chlorination at the point of collection on child diarrhoea in urban Bangladesh: a double-blind, cluster-randomised controlled trial. Lancet Glob Health. 2019 Sep;7(9):e1247-e1256. doi: 10.1016/S2214-109X(19)30315-8.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): December 20, 2016
• Study Completion (ACTUAL): December 20, 2016

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (ESTIMATE): November 17, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Water treatment; Child growth; Enteric infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Infections; Communicable Diseases; Diarrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamins; Ascorbic Acid
• Other Study ID Numbers: 30456