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
|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|
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).
- 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).
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 (Clinical Trial)|
|Actual Enrollment :||1549 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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)
- 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
- 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
- Height-for-age-z-score [ Time Frame: Measured at baseline and 16 months after baseline ]Height-for-age z-score among children under five
- 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
- C-reactive protein [ Time Frame: Measured at baseline and conclusion of study (16 months post baseline) among children under five ]
- total immunoglobin G (IgG) [ Time Frame: Measured at baseline and conclusion of study (16 months post baseline) among children under five ]
- Prevalence and number of enteric pathogens [ Time Frame: Measured 6-12 months after intervention delivery among children under five ]
- 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
- 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
- Chlorine residual in household stored drinking water [ Time Frame: Measured every 2-3 months for 16 months post baseline ]Free chlorine residual in ppm
- health related treatment and associated cost [ Time Frame: Measured every 2-3 months for 16 months post baseline ]
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
|Tongi and Dhaka Uddan|
|Tongi/Dhaka, Gazipur, Bangladesh|
|Principal Investigator:||Stephen Luby, MD||Stanford University|
|Study Director:||Amy Pickering, PhD||Stanford University|