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Automatic Chlorination and Child Health in Urban Bangladesh

Primary Purpose

Diarrhea, Communicable Diseases

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Water chlorination by the Flogenic
Active control, vitamin C dosing into water
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring Water treatment, Child growth, Enteric infection

Eligibility Criteria

undefined - 60 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tongi and Dhaka Uddan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Chlorination

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Weight-for-age-z-score
Weight-for-age z-score among children under five years
Height-for-age-z-score
Height-for-age z-score among children under five
Respiratory illness longitudinal prevalence
one week recall period, symptoms include congestion, cough, difficulty breathing
C-reactive protein
total immunoglobin G (IgG)
Prevalence and number of enteric pathogens
Caregiver defined diarrhea
1-week recall period, defined with local Bengali word for diarrhea

Full Information

First Posted
October 20, 2015
Last Updated
May 10, 2017
Sponsor
Stanford University
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT02606981
Brief Title
Automatic Chlorination and Child Health in Urban Bangladesh
Official Title
Evaluating Low-cost Automatic Water Disinfection Systems to Improve Water Quality and Child Health in Urban Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 20, 2016 (Actual)
Study Completion Date
December 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Communicable Diseases
Keywords
Water treatment, Child growth, Enteric infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1549 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorination
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Water chlorination by the Flogenic
Other Intervention Name(s)
Flogenic by Medentech
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Active control, vitamin C dosing into water
Other Intervention Name(s)
Vitamin C dosing device (not commercially available)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diarrhea longitudinal prevalence
Description
1-week recall period, case definition is 3 or more loose/watery bowel movements in 24 hours
Time Frame
Measured every 2-3 months for 16 months post baseline
Secondary Outcome Measure Information:
Title
Weight-for-age-z-score
Description
Weight-for-age z-score among children under five years
Time Frame
Measured every 2-3 months for 16 months post baseline
Title
Height-for-age-z-score
Description
Height-for-age z-score among children under five
Time Frame
Measured at baseline and 16 months after baseline
Title
Respiratory illness longitudinal prevalence
Description
one week recall period, symptoms include congestion, cough, difficulty breathing
Time Frame
Measured every 2-3 months for 16 months post baseline
Title
C-reactive protein
Time Frame
Measured at baseline and conclusion of study (16 months post baseline) among children under five
Title
total immunoglobin G (IgG)
Time Frame
Measured at baseline and conclusion of study (16 months post baseline) among children under five
Title
Prevalence and number of enteric pathogens
Time Frame
Measured 6-12 months after intervention delivery among children under five
Title
Caregiver defined diarrhea
Description
1-week recall period, defined with local Bengali word for diarrhea
Time Frame
Measured every 2-3 months for 16 months post baseline
Other Pre-specified Outcome Measures:
Title
Microbial water quality
Description
Colony forming units of the fecal indicator bacteria, E. coli
Time Frame
Measured monthly among a subset of households, for 16 months post baseline
Title
Chlorine residual in household stored drinking water
Description
Free chlorine residual in ppm
Time Frame
Measured every 2-3 months for 16 months post baseline
Title
health related treatment and associated cost
Time Frame
Measured every 2-3 months for 16 months post baseline

10. Eligibility

Sex
All
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Luby, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy Pickering, PhD
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Tongi and Dhaka Uddan
City
Tongi/Dhaka
State/Province
Gazipur
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
31402005
Citation
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.
Results Reference
derived

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Automatic Chlorination and Child Health in Urban Bangladesh

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