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Automatic Chlorination and Child Health in Urban Bangladesh

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ClinicalTrials.gov Identifier: NCT02606981
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : May 12, 2017
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Stephen P Luby, Stanford University

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.

Condition or disease Intervention/treatment Phase
Diarrhea Communicable Diseases Device: Water chlorination by the Flogenic Device: Active control, vitamin C dosing into water Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1549 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating Low-cost Automatic Water Disinfection Systems to Improve Water Quality and Child Health in Urban Bangladesh
Study Start Date : July 2015
Actual Primary Completion Date : December 20, 2016
Actual Study Completion Date : December 20, 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Vitamin C dosing device (not commercially available)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606981


Locations
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Bangladesh
Tongi and Dhaka Uddan
Tongi/Dhaka, Gazipur, Bangladesh
Sponsors and Collaborators
Stanford University
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Stephen Luby, MD Stanford University
Study Director: Amy Pickering, PhD Stanford University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stephen P Luby, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02606981    
Other Study ID Numbers: 30456
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Keywords provided by Stephen P Luby, Stanford University:
Water treatment
Child growth
Enteric infection
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Diarrhea
Signs and Symptoms, Digestive
Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents